Cleared Traditional

K220974 - R:GEN (FDA 510(k) Clearance)

K220974 · Lutronic Vision, Inc. · Ophthalmic device

Dec 2022

Decision

267d

Days

Class 2

Risk

K220974 is an FDA 510(k) clearance for the R:GEN. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).

Submitted by Lutronic Vision, Inc. (Billerica, US). The FDA issued a Cleared decision on December 27, 2022, 267 days after receiving the submission on April 4, 2022.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K220974 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 04, 2022
Decision Date	December 27, 2022
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF