Atlas FDA

HQG

56 FDA 510(k) clearances · Product code

44 daysmedian time to decision
140 days90th percentile
56clearances measured

FDA profile

Official device name
Lens, Spectacle, Non-Custom (Prescription)
Device class
Class I (low risk)
Regulation
21 CFR 886.5844
Medical specialty
Ophthalmic
Adverse events (MAUDE)
1994: 1 · 2000: 2 · 2001: 1 · 2002: 1 · 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SUNGLASSES (K935919)Ja-Ru, Inc.1994-02-16
0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX (K920795)Optical Radiation Corp.1992-07-13
MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR (K900091)Onufryk Low Vision Ent.1990-04-04
SEIKO P-6 PROGRESSIVE SPECTACLE LENSES (K884360)Seiko Corp.1988-11-15
NEOLENS PRESCRIPTION SPECTACLE LENS (K882814)Neolens, Inc.1988-07-29
CR-39 PLASTIC LENSES FOR EYEGLASSES (K882308)Automated Lens System1988-07-22
OPHTHALMIC SPECTACLE LENS BLANKS (K881225)Beta Optical Co, Inc.1988-04-19
SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P. (K875063)Epson EL Paso, Inc.1988-02-22
SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES (K874681)Klockner Contract Packaging, Inc.1988-02-05
AR DIACOAT SINGLE VISION LENSES (K873245)Seiko Optical Products of America, Inc.1987-10-05
MELANITE I (K872506)Aura Lens Products1987-07-27
MULTIPLE SPECTACLE LENS (K871961)Korea Asahi Optical Co., Ltd.1987-06-03
KROM-X LENS SYSTEM (K865103)Neo Optics, Inc.1987-01-20
FORMALENS 2000 (K863367)Vision-Sciences, Inc.1986-09-26
TECHNA VISION CASTING RESIN (K862578)Techna Vision1986-07-23
GOTTEX SUNGLASSES (K861021)Private Eyes Sunglass Corp.1986-06-17
SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS) (K861684)Seiko Optical Products of America, Inc.1986-06-09
LENS SPECTACLE NON-CUSTOM (PRESCRIPTION) (K861162)Efop1986-06-09
ZIMLITE LENS (K861960)Asahi Optical Co. C/O Rosati Associates, P.C.1986-06-09
GIRARD SUNGLASSES (NON-PRESCRIPTION) (K861759)H. Girard S.A.1986-06-09
WRAPPERS, SUNGLASSES (K860794)Mhci Corp.1986-04-21
SPECTACLES LENS (K860955)Roseburg SA1986-03-31
THE ULTRA-MATE LENS (K854218)Optical Systems Intl., Inc.1985-11-12
O.M.S. UV-COLOURS (K851410)Optical Moulding Systems1985-08-27
AURALITE II (K852403)Aura Lens Products1985-08-20
SPECTACLE PRESCRIPTION LENSES (K853110)Ancie Laboratories1985-08-09
SUNGLASES (K851163)Full See Glasses Ind. Co., Ltd.1985-05-30
CR-39 TYPE RESIN (K850905)Orplex Corp.1985-03-20
SUNGLASSES (K844778)B & M Sporting Goods, Inc.1985-01-04
MULTIPLE LENS, SPECTACLES, CUSTOM (K842187)Pavuna , Ltd.1984-12-11
MULTIPLE LENS, SPECTACLES CUSTOM (K842189)Hanmy Optical Industrial Co.1984-12-11
CUSTOM LITE (K844321)Buchmann Optical Industries1984-11-27
CRISTY/COTE (K843096)Titmus Optical, Inc.1984-11-21
SUNGLASSES (K841248)China Toy & Novelty Co., Ltd.1984-07-27
MULTIPLE (K833259)Sun House Products Co.1984-04-02
NOSITE UV INTERIM SPECTACLES (K823825)Patton, Boggs & Blow1983-02-24
SUNGLASS LENSES (K822573)ZEISS1982-10-22
CORNING CPF 550 LENS (K821398)Corning Medical & Scientific1982-06-25
SUNGLASSES (K813130)Panlin Corp.1982-03-04
DI-CROWN (K812441)Coburn Optical Ind., Inc.1981-10-06
PHOTOLITE AOLITE TINTOMATIC LENS (K812051)American Optical Corp.1981-09-08
BARNES-HIND SPECTACLE LENS CLEANER (K811554)Barnes-Hind, Inc.1981-07-02
BLENDED BIFOCAL (K802749)Robinson-Houchin, Inc.1980-12-17
POSTOPERATIVE UV GLASSES (PLANO/APHAKIC) (K802651)Chiron Vision Corp.1980-12-17
THE LENS OR OMMI-GARD (K800521)Gentex Corporation1980-03-12
BARNES-HIND WETTING & SOAKING SOLUTION (K791901)Barnes-Hind, Inc.1979-11-16
ULTRAVUE BLENDED BIFOCAL LENS (K791721)American Optical Corp.1979-10-23
LENS, POLYCORE (K790215)Polycore Optical Pte , Ltd.1979-02-26
FUL-VUE ASPHERIC CATARACT LENS (K790251)American Optical Corp.1979-02-26
HUMAN II LENS (K781927)Spectra-Shield, Inc.1978-12-20
LENS, HARD RESIN (K772221)Borani Intl.1978-01-30
LENSES, EYEGLASS, SAFETY (K772124)Techsight Corp.1977-11-16
RX LENS SERIES (K772024)Gentex Corporation1977-11-09
TECHSIGHT LENSES WITH ZUMA COATING (K772044)Techsight Corp.1977-11-09
MIRACLELENS (K770955)M.R.M. Optics, Inc.1977-06-17
AD7 PLASTIC MULTIFOCAL EYEGLASS LENS (K761163)American Optical Corp.1976-12-16

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Every clearance here is in the API, with alerts when new ones post.