Atlas FDA

RxSight Contact Lens

FDA 510(k) clearance K201909 · decided 2020-09-10

Clearance details

K-number
K201909
Device name
RxSight Contact Lens
Applicant
Rxsight, Inc.
Decision
Substantially Equivalent
Date received
2020-07-09
Decision date
2020-09-10
Days to decision
63 days
Clearance type
Traditional
Product code
HJK
Device class
2
Regulation number
886.1385
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Aliso Viejo, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Light Adjustable Lens and Light Delivery Device (P160055/S052)Rxsight, Inc.2025-10-08
LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) (P160055/S045)Rxsight, Inc.2025-09-02
RxSight Light Adjustable Lens (LAL), Light Delivery Device (LDD) (P160055/S051)Rxsight, Inc.2025-07-14
Light Adjustable Lens, Light Delivery System (P160055/S046)Rxsight, Inc.2025-06-11
Light Adjustable Lens and Light Delivery Device (P160055/S044)Rxsight, Inc.2025-05-19
Light Adjustable Lens and Light Delivery Device (P160055/S048)Rxsight, Inc.2025-05-12
LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) (P160055/S047)Rxsight, Inc.2025-05-02
Light Adjustable Lens, Light Delivery Device (P160055/S043)Rxsight, Inc.2025-04-17