Atlas FDA

Endocular Viewing Lenses and Silicone Ring

FDA 510(k) clearance K173944 · decided 2018-10-25

Clearance details

K-number
K173944
Device name
Endocular Viewing Lenses and Silicone Ring
Applicant
Phakos
Decision
Substantially Equivalent
Date received
2017-12-26
Decision date
2018-10-25
Days to decision
303 days
Clearance type
Traditional
Product code
HJK
Device class
2
Regulation number
886.1385
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Montreuil, FR
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Phakos

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
RxSight Contact Lens (K201909)Rxsight, Inc.2020-09-10
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

Recalls involving this device

No recalls on record reference this clearance.