Atlas FDA

HJK

41 FDA 510(k) clearances · Product code

58 daysmedian time to decision
159 days90th percentile
41clearances measured

FDA profile

Official device name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1385
Medical specialty
Ophthalmic
Flags
Third-party review eligible
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RecordFirmDate
RxSight Contact Lens (K201909)Rxsight, Inc.2020-09-10
Endocular Viewing Lenses and Silicone Ring (K173944)Phakos2018-10-25
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens (K151961)Volk Optical, Inc.2015-08-18
Sensor Medical Family of Vitrectomy Lenses and Products (K142715)Sensor Medical Technology, LLC2014-12-16
SUPER VIEW DISPOSABLE BIOM LENS SET (K051630)Insight Instruments, Inc.2005-06-29
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY (K051103)Haag-Streit USA, Inc.2005-06-07
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D (K050623)Volk Optical, Inc.2005-03-28
DORC VITRECTOMY LENSES, MODEL 1284 SERIES (K033950)Dutch Ophthalmic Research Center (D.O.R.C.)2004-02-20
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (K030054)Fci Ophthalmics, Inc.2003-02-26
CONTACT LASER & DIAGNOSTIC LENSES (K023221)Volk Optical, Inc.2002-10-11
LUNEAU 3 MIRROR LENS (K022413)Luneau SA2002-09-24
STAURENGHI WIDE FIELD SCANNING LASER LENS (K014170)Ocular Instruments, Inc.2002-03-04
DISPOSABLE VITRECTOMY LENS (K012096)Ocular Instruments, Inc.2001-08-24
ENDOVIEW SPPHIRE LENS SET (K971853)American Medical Devices, Inc.1997-08-06
MANDELKORN SUTURE LYSIS LENS (K933976)Ocular Instruments, Inc.1994-11-08
RITCH NYLON SUTURE LASER LENS (K933264)Ocular Instruments, Inc.1994-10-31
VIRECTOMY LENS (K940107)Visionary Technologies of Miami, Inc.1994-09-06
QUADRASPHERIC FUNDUS LENS (K943125)Volk Optical, Inc.1994-09-02
50 DEGREE HRI PRISM LENS (K941420)Ocular Instruments, Inc.1994-08-29
PEDIATRIC VITRECTOMY LENS SET (K914051)Ocular Instruments, Inc.1991-12-09
LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET (K914117)Ocular Instruments, Inc.1991-11-13
MAINSTER HIGH MAGNIFICATION LASER LENS (K912366)Ocular Instruments, Inc.1991-06-25
NMR-K FUNDUS LASER LENS (K910231)Ocular Instruments, Inc.1991-01-28
MAINSTER WIDE FIELD LASER LENS (K896198)Ocular Instruments, Inc.1989-12-18
WOLDOFF PRISMATIC BICONCAVE LENS (K894421)Ocular Instruments, Inc.1989-10-04
HOSKINS-BARKAN GONIOTOMY LENS 10MM (K875330)Ocular Instruments, Inc.1988-02-26
BICONCAVE VITRECTOMY LENS (K875331)Ocular Instruments, Inc.1988-02-26
PEYMAN G. 12.12 YAG LASER LENS (K875087)Ocular Instruments, Inc.1988-02-19
HOSKINS-BARKAN GONIOTOMY LENS 9MM (K875114)Ocular Instruments, Inc.1988-02-19
18MM PEYMAN WIDE FIELD YAG LASER LENS (K872855)Ocular Instruments, Inc.1987-09-04
12.5MM PEYMAN WIDE FIELD YAG LASER LENS (K872136)Ocular Instruments, Inc.1987-06-19
25MM PEYMAN WIDE FIELD YAG LASER LENS (K871450)Ocular Instruments, Inc.1987-06-03
YANNUZZI FUNDUS LASER LENS (K864304)Ocular Instruments, Inc.1986-12-15
MAINSTER RETINA LASER LENS (K863911)Ocular Instruments, Inc.1986-12-12
LANDERS INDIRECT VITRECTOMY LENS (K864418)Ocular Instruments, Inc.1986-11-28
ABRAHAM YAG LASER LENS (K862868)Ocular Instruments, Inc.1986-08-21
HOSKINS NYLON SUTURE LASER LENS (K862728)Ocular Instruments, Inc.1986-08-21
SCHIRMER PERIPHERAL IRIDECTOMY LASER LENS (K863027)Ocular Instruments, Inc.1986-08-21
WISE IRIDOTOMY-SPINCTEROTOMY LENS (K861648)Ocular Instruments, Inc.1986-06-19
LENS-EZE (K862094)Insight International, Inc.1986-06-19
SURGICAL EYE SHIELD (K781960)Concept, Inc.1979-02-09

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