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
5110
Total
5092
Cleared
168d
Avg (2y)
1976
Since
2899 Ophthalmic devices
Cleared
Jan 25, 1994
AOD4000 DISPOSABLE PAK
HQC
Unit, Phacofragmentation
314d
Cleared
Jan 25, 1994
STORZ FIBEROPTIC REVERSE CUTTING KNIFE
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
162d
Cleared
Jan 25, 1994
ELECTRIC I/V POLE OR EIVP2
KYG
Device, Irrigation, Ocular Surgery
98d
Cleared
Dec 27, 1993
VISI-SPEAR EYE SPONGE
HOZ
Sponge, Ophthalmic
143d
Cleared
Dec 14, 1993
BARE-FIBER ENDOILLUMINATOR
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
166d
Cleared
Dec 06, 1993
MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE
KYG
Device, Irrigation, Ocular Surgery
378d
Cleared
Dec 03, 1993
DE LUXE
HLJ
Ophthalmoscope, Battery-powered
385d
Cleared
Nov 22, 1993
NIDEK MODEL AC-2300
HQF
Laser, Ophthalmic
164d
Cleared
Nov 12, 1993
SITE'S CD II PHACOEMULSIFICATION HANDPIECE
HQC
Unit, Phacofragmentation
212d
Cleared
Nov 12, 1993
MODIFICATION OF SURGICAL EYESHIELD MASK
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
84d
Cleared
Oct 18, 1993
UNI II
HLJ
Ophthalmoscope, Battery-powered
339d
Cleared
Oct 15, 1993
RI-FORMER
HLJ
Ophthalmoscope, Battery-powered
147d
Cleared
Sep 09, 1993
ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR
HJO
Biomicroscope, Slit-lamp, Ac-powered
304d
Cleared
Aug 24, 1993
CLARUS ENDOSCOPIC HOOK KNIFE
HLX
Photostimulator, Ac-powered
284d
Cleared
Aug 17, 1993
HGM ASPIRATING ENDOOCULAR(TM) PROBE
HQF
Laser, Ophthalmic
280d
Cleared
Aug 03, 1993
BIO-PEN SRK II CALCULATOR
LQB
Medical Computers And Software For Ophthalmic Use
427d
Cleared
Aug 03, 1993
OPHTHALMOSCOPE
HLJ
Ophthalmoscope, Battery-powered
263d
Cleared
Jun 28, 1993
OPTI-FREE CONTACT LENS CASE
LRX
Case, Contact Lens
87d
Cleared
Jun 22, 1993
TIP & MEMBRANE ASSEMBLY
HKX
Tonometer, Ac-powered
483d
Cleared
Jun 21, 1993
MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE
HLI
Ophthalmoscope, Ac-powered
167d
Cleared
Apr 14, 1993
BURTON AUTOMATIC PROJECTOR - MODEL CP-40
HOD
Clamp, Eyelid, Ophthalmic
203d
Cleared
Apr 14, 1993
BURTON SLIT LAMP - MODEL 850
HJO
Biomicroscope, Slit-lamp, Ac-powered
203d
Cleared
Apr 14, 1993
BURTON TRIAL LENS SET
HPC
Set, Lens, Trial, Ophthalmic
203d
Cleared
Apr 05, 1993
BURTON OPHTHALMIC STAND - MODEL XL3200
HMF
Stand, Instrument, Ac-powered, Ophthalmic
194d
Cleared
Apr 05, 1993
BURTON LENSMETER - MODEL 2021
HLM
Instrument, Measuring, Lens, Ac-powered
194d
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