Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1825014

FEI Number

1825014

Entity Name

Skytron, LLC

City/State/Country

Grand Rapids, MI, US

Establishment Address

5085 Corporate Exchange Blvd SE, Grand Rapids, MI 49512, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Skytron, LLC (Owner Number: 9918015)

Owner / Operator Contact Address

5085 Corporate Exchange Blvd SE, --, Grand Rapids, MI 49512, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VOIRELITE SURGICAL DISPLAY Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series Aurora Astro Series, DoVera Series, DoVera 2 Series Lumos Series Ergon Series Skybooms; Freedom Series Skybooms; Various Models of Skybooms Shoulder support (pr) KUB Board 96" restraint strap (velcro fastener) Angle block adapter for pendant controls 1602 X-ray top set "L" type anesthesia screen with two adjustable wings, without clamp Skytron beach chair Levitator accessory cart kit for use with 6-020-10 E-Z Lift assist beach chair Shoulder chair accessory cart kit for use with 6-020-10 Radiographic top (3501C) Anesthesia screen, "wing" type with clamps Radiolucent standard armboard (without pad) Transfer board, pin type (6002, 1700, 6700 series & 3600B) Schure Socket XL Auxiliary base connector kit (3000) Radiographic top (6700 series) Uro drain tray with mounting brackets (6002 & 6700 series) Radiographic top (1700) Ortho Trax System Patient security straps with velcro Organizer, stirrup kit Premium locking armboard Table side extension (3-1/2" x 15" with side rails Basket accessory cart kit for use with 6-020-10 Clamp on rail 47.5" Nissen strap set Premium Armboard Multi-task armboard w/pad (requires clamp) (Sure Clamp 6-040-11 recommended) Knee/calf ankl-lock crutches with pads and without clamps Uro drain tray with mounting brackets (3100A) Organizer, wall mount General purpose head support Universal split leg accessory w/2" pad Flexfit 600 stirrups Auxiliary base connector kit (3003) Standard Armboard 40" Carbon fiber extension for 3600B & 6700 series Heavy duty levitator stirrups, blade type, without clamps, with pads and straps Instrument tray Auxiliary base connector installation 12" Carbon fiber arm surgery board for 3000 & 3003 (36" & 48" extensions) Transfer board pin type (3600B & 6700 series) Universal side rail clamp II Auxiliary base connector kit (1700) Pivoting Carbon fiber clamp-on armboard for 3000 & 3003 (36" & 48" extensions) Lithotomy stirrups (pr) without clamps Head end uro tray adapter for crescent type uro metal tray (adapter only) Narrow head section (6002, 1700, 3600B & 6700 series) Pediatric Extension Ankl-lock III lithotomy stirrups without clamps, with pads and straps 58.5" snap restraint strap Lateral brace for shoulder positioners Radiographic top for KUB board Foot control - 3 function (3003) (Trend, tilt, elev) Adapter to attach 3-040-20 to leg pins Urology bracket set 105" restraint strap (2 buckles) OB Hand grips (pr) Straps for 4-020-02-4 (pr) Head end uro tray adapter with uro drain tray crescent type (1700, 6002 & 6700 series) Neuro adapter Chest and waist support (pr) Uro drain tray with mounting brackets (3600B) Foot control - 3 function (6700 series) (Trend, tilt, elev) Levitator stirrups, blade type, without clamps, with pads and straps 75" patient safety strap (two piece 37"/38") Nylon restraint belt with velcro Bar clamp (use with chest and waist supports only) Split leg section for 6700 series & 3600B Springloc clamp Auxiliary base connector kit (3501B) Carbon Fiber Armboard for 3000 and 3003 (slide under pad type) Foot rests (pr) Head end uro tray adapter for rectangular type metal tray (adapter only) Silhouetted narrow head section (6002, 1700, 3600B & 6700 series) no side rails, includes a 2" pad Radiographic top (3600B) Lower back section - 6700 series/3600B (for use with split leg accessory 4-030-61) 96" restraint strap (2 buckles) EZ-Roll cart 18" foot extension with built in clamps and hd support rod Tri-clamp - round or flat bar Raised Armboard without clamp Prone positioning frame (cloward saddle) 40" carbon fiber accessory kit for use with 6-020-10 Radiographic top (6300) Catheter extension Cart, Ortho Trax 18" knee rest Anesthesia screen "L" type without clamp Heavy duty support rod for flat bar clamp Foot Control 3502/6302 10" foot extension without pad Heavy duty support rod for round bar clamp Softee strap EZ grip bar clamp for HD levitators Beach chair head rest upgrade dual ball joint 5 piece split leg accessory cart kit for use with 6-020-10 Side Rail extension and clamp assembly (7") Foot Control 3602/6702 Transfer board, side rail type (3100A, 6002, 1700, 6700 series & 3600B) Standard bar clamp Angle block installation 2" restraint strap (65" two pieces 42"/23")(1 buckle) Skytron Urology Bracket G-Series Light Weight Leg Section G-Series 44" Carbon Fiber Extension Versa Fit Bariatric Boot (sold as a pair) G-Series KUB Versa Fit Standard Boot (sold as a pair) G-Series Pediatric Extension Flex Fit 2 Versa Fit Elite Boot (sold as a pair) Versa Fit G-Series Clamp Skytron Lat Brace "New Style" Red 3-060-08 5 Side Extension New Style Double Ball Joint Head Section Sterilizable Handle/Adapter for Various Model Surgical Lights Sterilizable Camera Cover for Various Model Surgical Lights Sterilizable Center Focus Handle Adapter TV light to Center Focus Handle Stellar, Aurora LED and Aurora II Lights W1 and W2 Series 6702 Hercules, 6302 Elite, 1602 Essentia, 3602 UltraSlide, 3502 EZ Slide, 3003 Impulse 3603 UltraSlide, 3603H UltraSlide, 3503 EZ Slide 3008 Clarity GS70 SALUS, GS70H SALUS Stellar Series Surgical Lights HA60AR/AR24 Spectra AUT1 series TR-7; HALUX LED 20; Iris LED Lucina 4 DoVera DE12 Series Skytron 1602SL 3" SofPad II Pad Set Skytron 6700 Series 2" SofPad II Pad Set Skytron Replacement Leg section 3" SofPad II Type C 21.5" long Skytron 1700 2" SofPad II Pad Set Skytron Replacement Leg section 3" SofPad II Type A 23.75" long Skytron 6700 Series 3" SofPad II Pad Set Skytron 1602SL 4" SofPad II Pad Set Skytron Replacement Leg section 3" SofPad II Type D 25.5" long Skytron Replacement Head section 2" SofPad II Type A 9.5" long Skytron Replacement Leg section 4" SofPad II Type D 25.5" long Skytron 3501B, 3501C, 3502, 3503, 3600, GS70, GS50 2" SofPad II Pad Set Skytron 3501B, 3501C, 3502, 3503, 3600, GS70, GS50 4" Bariatric SofPad II Pad Set Skytron Replacement Head section 3" SofPad II Type B 12.63" long Skytron 1602 2" SofPad II Pad Set Skytron 3000 Series 3" SofPad II Pad Set Skytron 3501B, 3501C, 3502, 3503, 3600, GS70, GS50 2" Bariatric SofPad II Pad Set Skytron 6300 Series 3" SofPad II Pad Set Skytron 6700 Series 4" SofPad II Pad Set Skytron 6300 Series 2" SofPad II Pad Set Skytron 3000 Series 2" SofPad II Pad Set Skytron 6300 Series 4" SofPad II Pad Set 2" Welded Seam Pad 18" Foot Extension/Knee Rest 3" 3-piece extra wide Bariatric Sof-Pad set (3600B) 4" 3PC Pad Set 6300 Welded Seam 3" Sof-Pad for Transfer Board (4-030-22) 4" Sof-pad for split leg accessory (right) 4" 3PC Pad Set 6002 Welded Seam 2" 3PC Pad Set 1700 Welded Seam 3" Sof-Pad for radiolucent & premium armboards 4" pad for pivoting carbon fiber armboard 4" 5-piece Sof-Pad set for split leg section 3" 3PC Pad Set 6002 Welded Seam 5" 3PC PAD SET: 3501B, 3501C, 3502, 3503, 3600 SERIES WELDED SEAMS 2" Sof-Pad for radiolucent & premium armboards 5" 3PC Pad Set 6700 Series Welded Seam 3" Welded Seam Pad for Pivoting Carbon Fiber Armboard 2" Sof-Pad for 14" Bari Foot Extension 4" 5-piece standard pad set for split leg section 3" 3PC Pad Set 6300 Welded Seam 4" Sof-pad for 5" table side extension (ea.) 3" Standard Pad for Transfer Board (4-030-22) 2" Welded Seam Pad for Pivoting Carbon Fiber Armboard 3" Sof-pad for 3-1/2" table side extensions (ea.) 2" Standard Pad for Transfer Board (4-030-22) 4" Pad for 5" table side extension (ea.) 4" Sof-pad for 10" foot extension 5" Pad 3000/3003 Welded Seam 2" Pad for 12" carbon fiber arm surgery board 4" 3PC Pad Set 1700 Welded Seam 4" Pad for 40" Carbon Fiber Extension 4" Sof-Pad for radiolucent & premium armboards 5" Welded Seam Pad for Pivoting Carbon Fiber Armboard 5" 5-piece Sof-Pad set for split leg section 3" Pad 3000/3003 Welded Seam 2" 3PC Pad Set 6700 Series Welded Seam 5" Sof-Pad for radiolucent & premium armboards 2" Pad for 10" foot extension 2" Sof-pad for 5" table side extension (ea.) 2" Pad for 40" Carbon Fiber Extension 2" Sof-Pad for Carbon Fiber Armboard 2" Sof-pad for 10" foot extension 2" 5-piece Sof-Pad set for split leg section 2" Pad for 5" table side extension (ea.) 5" Sof-pad for 3-1/2" table side extensions (ea.) 4" 3PC Pad Set 6700 Series Welded Seam Standard Singer Starr Stacker Knee crutch Sof-Pads (pr.) 5" 3PC Pad Set 6002 Welded Seam 4" Welded Seam Pad 18" Foot Extension/Knee Rest 4" Sof-Pad for 14" Bariatric Foot Extension 2" Sof Pad for Split Leg Foot Rest (4-030-04) 3" 3PC Pad Set 6700 Series Welded Seam 3" Welded Seam Pad 18" Foot Extension/Knee Rest Singer Starr Stacker Bariatric pad set 5" Sof-pad for 5" table side extension (ea.) 3" Sof-Pad for 14" Bariatric Foot Extension Singer Starr Leg Stacker 2" pad for 3-1/2" table side extension (ea.) 2" Sof-pad for foot rests (pr.) 2" Pad 3000/3003 Welded Seam 5" Welded Seam Pad 18" Foot Extension/Knee Rest 2" 2PC Pad Set 3100 Welded Seam 4" Sof-Pad for 12" carbon fiber arm surgery board 5" Sof-Pad for 14" Bariatric Foot Extension 3" Sof-pad for 5" table side extension (ea.) 4" Sof-Pad for 40" Carbon Fiber Extension 2" Pad for narrow head section 4" Pad for 10" foot extension 4" Sof-pad for Pelvic tilt seat 2" 3PC Pad Set 6300 Welded Seam 4" Pads for foot rests (pr.) 2" Sof Pad for Transfer Board (4-030-22) 5" 2PC Pad Set 3100 Welded Seam 2" 3PC Pad Set 6002 Welded Seam 4" STANDARD OR RADIOLUCENT ARMBOARD PAD WELDED SEAM 4" 3PC PAD SET: 3501B, 3501C, 3502, 3503, 3600 SERIES WELDED SEAMS 2" pad for radiolucent & premium armboards 2" Sof-pad for 3-1/2" table side extension (ea.) 4" Sof-Pad for Transfer Board (4-030-22) 3" 5-piece Sof-Pad set for split leg section 4" Sof-pad for split leg accessory (left) 2" 3-piece extra wide Bariatric Sof-Pad set (3600B) 3" 3PC PAD SET: 3501B, 3501C, 3502, 3503, 3600 SERIES WELDED SEAMS 5" 3PC Pad Set 1700 Welded Seam 5" 3PC Pad Set 6300 Welded Seam Carbon Fiber Armboard for 3000 and 3003 (slide under pad type) 4" Standard Pad for Transfer Board (4-030-22) 3" 2PC Pad Set 3100 Welded Seam 4" 2PC Pad Set 3100 Welded Seam 3" STANDARD OR RADIOLUCENT ARMBOARD PAD WELDED SEAM 2" 5-piece standard pad set for split leg section 3" 3-3/4" 5pc. Standard Pad Set Split Leg 2" STANDARD OR RADIOLUCENT ARMBOARD PAD WELDED SEAM 2" 3PC PAD SET: 3501B, 3501C, 3502, 3503, 3600 SERIES WELDED SEAMS 2" Sof-pad for split leg accessory (right) 2" Sof-pad for split leg accessory (left) 4" Pad for narrow head section 5" STANDARD OR RADIOLUCENT ARMBOARD PAD WELDED SEAM 4" Pad for 3-1/2" table side extension (ea.) 3" 3PC Pad Set 1700 Welded Seam 4" pad for radiolucent & premium armboards 4" Welded Seam Pad for Pivoting Carbon Fiber Armboard 5" 5-piece standard pad set for split leg section 2" pad for pivoting carbon fiber armboard 4" Sof-pad for 3-1/2" table side extension (ea.) 4" Pad 3000/3003 Welded Seam Radiolucent standard armboard (without pad) 2" Sof-Pad for 40" Carbon Fiber Extension Pad Left Panel Pad Main Body Pad Right Panel S.C. Head Pad D Skytron Replacement Head section 3" SofPad II Type A 9.5" long Skytron 3501B, 3501C, 3502, 3503, 3600, GS70, GS50 4" SofPad II Pad Set Skytron 6700 Series 3" Bariatric SofPad II Pad Set Skytron Replacement Leg section 2" SofPad II Type A 23.75" long Skytron Replacement Leg section 2" SofPad II Type D 25.5" long Skytron 3000 Series 4" SofPad II Pad Set Skytron 3501B, 3501C, 3502, 3503, 3600, GS70, GS50 3" Bariatric SofPad II Pad Set Skytron Replacement Head section 2" SofPad II Type B 12.63" long Skytron 1700 3" SofPad II Pad Set Skytron Replacement Leg section 4" SofPad II Type A 23.75" long Skytron 1700 4" SofPad II Pad Set Skytron Replacement Leg section 2" SofPad II Type C 21.5" long Skytron 1602 3" SofPad II Pad Set Skytron Replacement Leg section 4" SofPad II Type C 21.5" long Skytron 6700 Series 4" Bariatric SofPad II Pad Set Pad Lateral Brace Skytron 3501B, 3501C, 3502, 3503, 3600, GS70, GS50 3" SofPad II Pad Set Skytron 6700 Series 2" Bariatric SofPad II Pad Set Skytron Replacement Head section 4" SofPad II Type B 12.63" long Pad Lateral Brace Curved Skytron 1602 4" SofPad II Pad Set Skytron Replacement Head section 4" SofPad II Type A 9.5" long Skytron 1602SL 2" SofPad II Pad Set Nautilus LED series Stellar XL Series Remote Camera Control Unit Aurora II and newer, Camera for Aurora 3 and Aurora 4 and Lumos Series, Camera for DoVera DM5 Optik View 31" Display W1 and W2 Series Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Sterilizer CleanStart Flex Surgical Instrument Washer Skytron I3; Skytron I5; Sterling Washer P1500, P1000, P1800 C2000-E480 C2000LW-E480 C2000-E208 C2000W-E480 C2000-S480 C2000LW-S480 C2000W-S208 C2000W-S480 C2000L-S208 C2000LW-S208 Sterling C2000 Series Cart Washer C2000W-E208 C2000L-E208 C2000-S208 C2000L-E480 C2000L-S480 C2000LW-E208 Skytron Carter Hand Surgery Table (Case) UroCatcher II Sterile Disposable Pouch Urology Bracket Set Sterile Cover for joystick of 3000 Series Tables Skytron Disposable Light Handle Cover Surgical Light Control Cleanview disposable handle cover Ascend Video Integration ESU Pencil Adapter Skytron Integrity 175 Steam Sterilizer; Skytron Integrity 175SG Steam Sterilizer SkyVision series, H1, H2, LINX, Ascend Video Integration SkyVision SDS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FWC	Camera, Television, Surgical, With Audio	General, Plastic Surgery	Class 1	878.4160	2024-10-16
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2016-05-18
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2007-11-07
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2015-04-22
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2016-05-03
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2019-11-26
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2015-04-22
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2007-11-07
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2015-04-22
LWG	Surgical Table Cushion	General, Plastic Surgery	Class 1	878.4950	2015-12-09
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2015-04-22
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2016-05-03
LHC	Warmer, Irrigation Solution	Physical Medicine	Class 1	890.5950	2016-02-17
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2015-12-09
MEC	Disinfector, Medical Devices	General Hospital	Class 2	880.6992	2015-12-09
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2016-05-18
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2016-07-18
IMY	Armboard, Wheelchair	Physical Medicine	Class 1	890.3910	2017-08-09
MMZ	Table, Cystometric, Electric	Gastroenterology, Urology	Class 2	876.4890	2016-04-04
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2020-02-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-04-04
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2015-12-09
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2015-12-10
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2015-12-09
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2015-05-05

Official Correspondent

Robert Vreeland

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Skytron, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780666	Castle Co.	DAYSTAR SELECTRA & SELECTRA/ORBITER	1978-04-27
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13
K021223	Sauter AG	BELIMED STEAM STERILIZER, MODEL TOP 5000	2002-06-26
K050263	M.O. Com S.R.L.	MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU	2006-11-21
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Similar Registrations

Registration Number	Establishment Name	Location
9611102	RICHARD WOLF GMBH	KNITTLINGEN Baden-Wurttemberg, DE
8030607	Industrias Apson S.A de C.V	AGUA PRIETA Sonora, MX
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
3021562244	ECLIPSE PRISM MEDICAL DEVICES PVT. LTD	RABALE, NAVI MUMBAI Maharashtra, IN
9610612	AESCULAP AG	TUTTLINGEN, DONAU Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1825014. Last updated year: 2026. Please use registration number 1825014 when referencing this establishment in official correspondence.