Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042228518

FEI Number

3042228518

Entity Name

AKRITI OPHTHALMIC PRIVATE LIMITED

City/State/Country

Hyderabad Telangana, IN

Establishment Address

M34 M35 M36 Medical Devices Park, Sultanpur, Hyderabad, Telangana, India, Hyderabad Telangana 502319, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Akriti Ophthalmic Private Limited (Owner Number: 10094067)

Owner / Operator Contact Address

M34 M35 M36 Medical Devices Park, Sultanpur, Hyderabad, Telangana, India, Hyderabad, IN-TG 502319, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Akriti Smart Technology Akriti Ophthalmic Smart Technology Akriti Akriti Smart Technology I-Drapes Smart Technology Akriti i-Read Dr Raizada Reading Glasses Akriti Smart Technology Akriti Akriti Smart Technology Smart Technology Akriti Smart Technology Akriti Akriti Smart Technology Akriti Smart Technology Akriti Smart Technology Akriti I-Shield Z-Kap Scleral Protector Akriti Smart Technology Akriti Lacriseal Smart Technology Akriti Smart Technology Akriti I-Blades MVR I-Blades Lance Tip I-Blade I-Blades Crescent Blades I-Blades Keratome Blades, Blunt Tip Smart Technology Akriti Akriti Smart Technology i-Wear Smart Technology Akriti Smart Technology Akriti Smart Technology Akriti Akriti Smart Technology I-Chart Akriti Smart Technology Smart Technology Akriti Smart Technology Akriti Smart Technology Akriti Akriti Smart Technology Akriti Smart Technology Smart Technology Akriti Akriti Smart Technology Smart Technology Akriti Akriti Smart Technology Akriti Colosseum Molly Diana Deccan Akriti Smart Technology Ocular Conformer Open fornix Conformer Ring Conformer I-Ring I-former Perforated Conformers Ocular Corneal Shield Symblepharon Ring Akriti Smart Technology Smart Technology Akriti Amnio-Ring Amnio-Ring Slim I-Sizer Orbital Implant Sizer Set Akriti Eyelid Gold Weight I-Weight Akriti Smart Technology Akriti Trephine Punch Trephine Punch (Vacuum) Akriti Jacob Cairs Trephine Punch (Non Vacuum) Smart Technology Akriti

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	2025-11-29
HQT	Shell, Scleral	Ophthalmic	Class 2	886.3800	2025-11-29
HOW	Drum, Opticokinetic	Ophthalmic	Class 1	886.1200	2025-11-30
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2025-11-29
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-29
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Ophthalmic	Class 1	886.5844	2025-11-29
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-29
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-29
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2025-11-29
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-29
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	2025-11-29
HNG	Rongeur, Lachrymal Sac	Ophthalmic	Class 1	886.4350	2025-11-29
HOH	Spectacle, Operating (Loupe), Ophthalmic	Ophthalmic	Class 1	886.4770	2025-11-30
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2025-11-29
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-29
PLX	Tear Duct Occluder	Ophthalmic	Class 1	886.5838	2025-11-29
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2025-11-29
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-29
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2025-11-29
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2025-11-25
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-29
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2025-11-29
HPD	Lens, Bagolini	Ophthalmic	Class 1	886.1375	2025-11-29
HJC	Esthesiometer, Ocular	Ophthalmic	Class 1	886.1040	2025-11-28
QTO	Digital Visual Acuity Test	Ophthalmic	Class 1	886.1150	2025-11-29
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-29
HNK	Probe, Trabeculotomy	Ophthalmic	Class 1	886.4350	2025-11-29
HOB	Clamp, Muscle, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-29
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2025-11-30
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-29
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2025-11-29
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2025-11-29
KYD	Strip, Schirmer	Ophthalmic	Class 1	886.1800	2025-11-29
NCK	Button, Iris, Eye, Artificial	Ophthalmic	Class 1	886.3200	2025-11-29
HQH	Eye, Artificial, Non-Custom	Ophthalmic	Class 1	886.3200	2025-12-09
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-29
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2025-11-29
HKR	Lens, Maddox	Ophthalmic	Class 1	886.1400	2025-11-29
HQN	Conformer, Ophthalmic	Ophthalmic	Class 2	886.3130	2025-11-28
HJT	Haploscope	Ophthalmic	Class 1	886.1340	2025-11-30
PYU	Sponge, Eyelid Cleaning, Powered	General, Plastic Surgery	Class 1	878.4820	2025-11-29
NQB	Conformer, Ophthalmic, Biological Tissue	Ophthalmic	Class 2	886.3130	2026-01-13
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2025-11-29
MML	Weights, Eyelid, External	Ophthalmic	Class 2	886.5700	2025-11-29
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-30
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-28
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-11-29

Official Correspondent

Kuldeep Raizada

US Agent Details

Arun Singh Business: Smart Technology LLC Email: arun@smarttech.foundation Phone: (216) 2192080

Related Public Records

Same Entity

Akriti Ophthalmic Private Limited

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
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K871646	Ocular Instruments, Inc.	TANNE CORNEAL CUTTING BLOCK	1987-05-18
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042228518. Last updated year: 2026. Please use registration number 3042228518 when referencing this establishment in official correspondence.