RxSight Contact Lens— 510(k) K201909

Substantially Equivalent

Rxsight, Inc.

FDA 510(k) clearance K201909 for RxSight Contact Lens, Substantially Equivalent on 2020-09-10. Applicant: Rxsight, Inc.. Device class: 2.

Clearance details

Applicant: Rxsight, Inc.
Product code: Code HJK
Device class: Class 2
Regulation: 21 CFR 886.1385
Advisory panel: Ophthalmic
Date received: 2020-07-09
Decision date: 2020-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HJK

K173944 — Endocular Viewing Lenses and Silicone Ring2018-10-25
K151961 — Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens2015-08-18
K142715 — Sensor Medical Family of Vitrectomy Lenses and Products2014-12-16
K051630 — SUPER VIEW DISPOSABLE BIOM LENS SET2005-06-29
K051103 — HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY2005-06-07

More clearances from Rxsight, Inc.

K261174 — RxSight® Insertion Device2026-06-10
K231838 — RxSight® Insertion Device (63002)2023-08-15
K231466 — RxSight Insertion Device2023-06-12
K192926 — RxSight Insertion Device2020-01-17
K181401 — RxSight Insertion Device2018-07-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.