FDA Review Panel · OP

FDA 510(k) Ophthalmic Devices

FDA 510(k) Ophthalmic Devices - Regulatory Overview

FDA 510(k) ophthalmic devices include diagnostic and surgical equipment for eye care. The FDA review panel code is OP.

Main categories:

  • Contact lenses - daily, extended wear, toric and multifocal lenses
  • Intraocular lenses (IOLs) - monofocal, toric and premium IOLs for cataract surgery
  • Ophthalmic lasers - excimer lasers for LASIK, Nd:YAG, photocoagulation
  • Retinal imaging systems - OCT, fundus cameras, fluorescein angiography
  • Diagnostic instruments - tonometers, perimeters, autorefractors, slit lamps

5119
Total
5101
Cleared
169d
Avg (2y)
1976
Since
5119 Ophthalmic devices
2051–2075 of 5119
Cleared Jul 14, 1997
SUNGLASSES
K971385 · Kosway Industries Co., Ltd.
HQY · Sunglasses (non-prescription Including Photosensitive) · 91d
Cleared Jul 14, 1997
MENTOR GEMINI HEMOSTATIC ERASER
K971538 · Mentor Ophthalmics, Inc.
HQO · Unit, Cautery, Thermal, Ac-powered · 77d
Cleared Jul 14, 1997
ALCON CONTACT LENS CASE
K971618 · Alcon Laboratories
LRX · Case, Contact Lens · 73d
Cleared Jul 14, 1997
AUTOMATED CHAMBER MAINTENANCE MODULE
K971795 · Paradigm Medical Industries, Inc.
HQC · Unit, Phacofragmentation · 60d
Cleared Jul 14, 1997
FOVS, BRILLARTE, ETC...
K972362 · Sunglass City, Inc.
HQY · Sunglasses (non-prescription Including Photosensitive) · 19d
Cleared Jul 07, 1997
OCULAR CONFORMER
K970318 · Southwest Artificial Eyes, Inc.
HQN · Conformer, Ophthalmic · 160d
Cleared Jul 07, 1997
OCULAR CONFORMER
K970319 · Xavier A. Guerra, Ocularist, Inc.
HQN · Conformer, Ophthalmic · 160d
Cleared Jul 07, 1997
SCLERAL SHELL
K970320 · Xavier A. Guerra, Ocularist, Inc.
HQT · Shell, Scleral · 160d
Cleared Jul 07, 1997
SCLERAL SHELL
K970327 · Southwest Artificial Eyes, Inc.
HQT · Shell, Scleral · 160d
Cleared Jul 03, 1997
MS401097-17,MS722-K,MS720,MS721,MS722
K962767 · Alexander Mfg. Co.
HLJ · Ophthalmoscope, Battery-powered · 352d
Cleared Jul 01, 1997
(BRAND NAME)
K971384 · Long IN Time Ent. Co., Ltd.
HQY · Sunglasses (non-prescription Including Photosensitive) · 78d
Cleared Jul 01, 1997
SUNGLASSES
K971462 · D.G. Prove Co.
HQY · Sunglasses (non-prescription Including Photosensitive) · 71d
Cleared Jun 30, 1997
MEDPOR OCULAR SCREW AND ACCEOSSORIES
K971583 · Porex Technologies Corp.
MQU · Ocular Peg · 61d
Cleared Jun 30, 1997
WELCH ALLYN PHACO ILLUMINATOR
K971750 · Welch Allyn, Inc.
HQC · Unit, Phacofragmentation · 49d
Cleared Jun 26, 1997
SPECTACLE FRAMES (NON-PRESCRIPTION)
K972246 · Alimar Trading, Inc.
HQY · Sunglasses (non-prescription Including Photosensitive) · 10d
Cleared Jun 25, 1997
I-SCOPE OPHTHALMIC ENDOSCOPE
K971679 · Ophthalmic Technologies, Inc.
MPA · Endoilluminator · 49d
Cleared Jun 24, 1997
ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)
K970882 · American Medical Devices, Inc.
MPA · Endoilluminator · 106d
Cleared Jun 24, 1997
CEBE
K971644 · Suunto USA
HQY · Sunglasses (non-prescription Including Photosensitive) · 50d
Cleared Jun 24, 1997
IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM
K971685 · Tomey Corporation USA
HKI · Camera, Ophthalmic, Ac-powered · 48d
Cleared Jun 24, 1997
SUNGLASSES (NON-PRESCRIPTION)
K972014 · Tamfort, Ltd.
HQY · Sunglasses (non-prescription Including Photosensitive) · 25d
Cleared Jun 24, 1997
RIVIERA SUNGLASS4ES
K972194 · Riviera Optical Co., Ltd.
HQY · Sunglasses (non-prescription Including Photosensitive) · 14d
Cleared Jun 20, 1997
BLINK EXTERNAL EYELID WEIGHT
K971245 · Ipax, Inc.
MML · Weights, Eyelid, External · 78d
Cleared Jun 17, 1997
BLOOD FLOW ANALYZER
K970887 · Paradigm Medical Industries, Inc.
HKY · Tonometer, Manual · 98d
Cleared Jun 17, 1997
STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
K971439 · Storz Instrument Co.
HQC · Unit, Phacofragmentation · 60d
Cleared Jun 13, 1997
SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC)
K971087 · W.J. Byrnes & Co. of Los Angeles, Inc.
HQY · Sunglasses (non-prescription Including Photosensitive) · 80d

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All categories 5119 HQY Sunglasses (non-prescription Including Photosensitive) 646 LPL Lenses, Soft Contact, Daily Wear 490 HQC Unit, Phacofragmentation 317 HQZ Frame, Spectacle 198 HQF Laser, Ophthalmic 179 HKI Camera, Ophthalmic, Ac-powered 156 HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered 148 LPN Accessories, Soft Lens Products 121 HQD Lens, Contact (other Material) - Daily 118 HJO Biomicroscope, Slit-lamp, Ac-powered 108 HLI Ophthalmoscope, Ac-powered 85 HNO Keratome, Ac-powered 83 LRX Case, Contact Lens 82 HMX Cannula, Ophthalmic 77 HPX Lens, Contact (polymethylmethacrylate) 74