Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003039352

FEI Number

3003039352

Entity Name

EPSILON EYE CARE PVT., LTD.

City/State/Country

MUMBAI Maharashtra, IN

Establishment Address

6B-301 SHWETA, ASHANAGAR WEH, Kandivali (E), MUMBAI Maharashtra 400 101, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EPSILON EYE CARE PVT., LTD. (Owner Number: 9042394)

Owner / Operator Contact Address

6B-301 SHWETA, ASHANAGAR, WESTERN EXPRESS HWY., Kandivali (E), MUMBAI, IN-MH 400-066, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Epsilon EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON Epsilon EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON EPSILON Epsilon Epsilon EPSILON EPSILON EPSILON EPSILON

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	2013-08-13
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-08-02
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-08-02
HNE	Snare, Enucleating	Ophthalmic	Class 1	886.4350	2000-08-02
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2000-08-02
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-08-02
HOB	Clamp, Muscle, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-08-02
HNT	Erisophake	Ophthalmic	Class 1	886.4350	2000-08-02
MOE	Collagen Corneal Shield	Ophthalmic	Class 1	886.4750	2000-08-02
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2000-08-02
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	2000-08-02
HNG	Rongeur, Lachrymal Sac	Ophthalmic	Class 1	886.4350	2000-08-02
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-08-02
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2013-01-02
HOF	Burr, Corneal, Manual	Ophthalmic	Class 1	886.4350	2013-01-02
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-08-02
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-08-02
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2000-08-02
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2013-01-02
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-02
HNK	Probe, Trabeculotomy	Ophthalmic	Class 1	886.4350	2000-08-02
HNP	Introducer, Sphere	Ophthalmic	Class 1	886.4350	2000-08-02
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2013-08-13
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-02
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-08-02
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-02
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-02
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2000-08-02
HNS	Expressor	Ophthalmic	Class 1	886.4350	2000-08-02
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-08-02
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-08-02
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	2013-08-13
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2013-08-13
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-08-02
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-02
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-08-02
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-02

Official Correspondent

No official correspondent registered.

US Agent Details

MOHAMMED IBRAHIM Business: FOCUS OPHTHALMICS, LLC Email: epsilon_usa@yahoo.com Phone: (909) 9844614

Related Public Records

Same Entity

EPSILON EYE CARE PVT., LTD.

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
K900478	Woodlyn, Inc.	WOODLYN FULL APERTURE TRIAL LENS SET	1990-02-21
K871646	Ocular Instruments, Inc.	TANNE CORNEAL CUTTING BLOCK	1987-05-18
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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3003951061	M/S TARUN ENTERPRISES	Prayagraj, Uttar Pradesh, IN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003039352. Last updated year: 2026. Please use registration number 3003039352 when referencing this establishment in official correspondence.