Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011910987

FEI Number

3011910987

Entity Name

KLYO MEDICAL SYSTEMS INC

City/State/Country

Doral, FL, US

Establishment Address

1464 NW 82nd Ave, Doral, FL 33126, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Klyo Medical Systems Inc (Owner Number: 10052269)

Owner / Operator Contact Address

1464 NW 82nd Avenue, Miami, FL 33126, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

E100 Series (E1-M, E1-C, E1-W) S200 Series (Mobile, Ceiling, Dual Ceiling, Wall) KL500-EH Surgical Tables KLYO Mechanical Surgical Tables and Electro Motorized Surgical Tables KL10 Surgical Tables KL100 Surgical Table KL175 Surgical Tables KL300-EH Surgical Table KL50 Surgical Tables KL400 Surgical Tables KL125 Surgical Tables KLRX-1 Surgical Table KL150 Surgical Tables KLRX-2 Surgical Table KL20 Surgical Tables KL300 Surgical Table KL500 Surgical Table KL200 Surgical Table KL40 Surgical Tables KL700 Surgical Tables KL60 Surgical Tables KL10-ST Surgical Tables KL30 Surgical Tables BF683 TDP BF683 EH E810 Series (Single, Double, Triple or Combination) Surgical Room Light System E600 Series (Single, Double, Triple or Combination) Surgical Room Light System E666 Series (Single, Double, Triple or Combination) Surgical Room Light System E880 Series (Single, Double, Triple or Combination) Surgical Room Light System E660 Series (Single, Double, Triple or Combination) Surgical Room Light System L200 Series (Single or Combination) Surgical Room Light System M200 Series (M200) (M210) (Single or Combination) Surgical Room Light System M300 Series (M300) (M310) (Single or Combination) Surgical Room Light Systems M400 Series (Single or Combination) Surgical Room Light System L400 Series (Single or Combination) Surgical Room Light System KLED-X4500-1 Ceiling Mount E888 Series (E888) (Single, Double, Triple or Combination) Surgical Room Light System Light System Attachments and Components E661 Series (Single, Double, Triple or Combination) Surgical Room Light System E800 Series (Single, Double, Triple or Combination) Surgical Room Light System E881 Series (Single, Double, Triple or Combination) Surgical Room Light System E610 Series (Single, Double, Triple or Combination) Surgical Room Light System KLED-X200-1 Ceiling Mount 350 KLED-X220-1 Ceiling Mount BARRPORT VARIOVIEW 32 KL100 Surgical Tables VISTA KL150 Surgical Tables VARIOVIEW KL700 Surgical Tables KL RX-2 Surgical Tables KL300 Surgical Tables KL RX-1 Surgical Tables Mediboom- Heavy Duty CEMOR Acrobat 2000 Acrobat 3000 Valia Suspension System (VALIA S, VALIS C) Medispace KL300-EH Surgical Tables KL500 Surgical Tables KLV200 Surgical Tables Spaceport Acrobat Swing MediLift- Heavy Duty KL125 Surgical Tables KL175 Surgical Tables KL200 Surgical Tables KLV100 Surgical Tables KLE 100 STP Surgical Tables Klyo O.R. Table and Attachments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2017-02-06
FWX	Table, Operating-Room, Mechanical	General, Plastic Surgery	Class 1	878.4950	2016-07-19
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2019-07-11
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2022-01-19
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2016-07-19

Official Correspondent

Luis Torres

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Klyo Medical Systems Inc

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
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13
K780666	Castle Co.	DAYSTAR SELECTRA & SELECTRA/ORBITER	1978-04-27
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011910987. Last updated year: 2026. Please use registration number 3011910987 when referencing this establishment in official correspondence.