Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1035968

FEI Number

1035968

Entity Name

SUNOPTIC TECHNOLOGIES, LLC

City/State/Country

JACKSONVILLE, FL, US

Establishment Address

6018 BOWDENDALE AVE., JACKSONVILLE, FL 32216, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

SUNOPTIC TECHNOLOGIES, LLC (Owner Number: 1035968)

Owner / Operator Contact Address

6018 BOWDENDALE AVE., --, Jacksonville, FL 32216, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Light Source LIGHT, SURGICAL, FIBEROPTIC Sunoptic Surgical TracLux Light Carrier Customer brand Sunoptics Surgical BRAND Cuda Sunoptics Surgical FIBEROPTIC HEADLIGHT SYSTEM Customer brand Cuda BRAND Customer Brand Sunoptics Surgical BRAND ILLUMINATOR FOR ENDOSCOPE FIBEROPTIC Cuda Lamp, operating-room LED HEADLAMP WITH BATTERY-PACK DPLS-01, Xenon Lightsource Sunoptics Surgical Cuda Customer brand BRAND Fiberoptic Cable Light source, fiberoptic, routine LIGHT, SURGICAL, FIBEROPTIC Sunoptics Surgical BRAND

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2003-04-21
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2003-04-21
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2020-06-19
FSZ	Light, Surgical, Carrier	General, Plastic Surgery	Class 2	878.4580	2021-09-08
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2007-11-16
EBA	Light, Surgical Headlight	Dental	Class 1	872.4630	2007-09-12
HBI	Illuminator, Fiberoptic, Surgical Field	General, Plastic Surgery	Class 2	878.4580	1992-07-08
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	1992-07-08
FFS	Image, Illumination, Fiberoptic, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	1992-07-08
FCR	Light Source, Photographic, Fiberoptic	Gastroenterology, Urology	Class 2	876.1500	1992-07-08
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	1992-07-08
FQP	Lamp, Operating-Room	General, Plastic Surgery	Class 2	878.4580	2020-03-24
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	Class 1	886.4335	2011-06-21
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2022-02-22
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2010-03-22
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	1992-07-08
FSW	Light, Surgical, Endoscopic	General, Plastic Surgery	Class 2	878.4580	2003-04-21
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2007-11-16
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2006-05-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SUNOPTIC TECHNOLOGIES, 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
K901491	Cuda Products Co.	CUDA SURGICAL LIGHT	1990-06-18
K936071	Smith & Nephew Dyonics, Inc.	SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE	1994-08-19
K953574	American Hydro-Surgical Instruments, Inc.	NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER	1995-09-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1035968. Last updated year: 2026. Please use registration number 1035968 when referencing this establishment in official correspondence.