Cleared Traditional

Biophotas Celluma RESTORE

K211038 · Biophotas, Inc. · General & Plastic Surgery

Jun 2021

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K211038 is an FDA 510(k) clearance for the Biophotas Celluma RESTORE, a Laser, Comb, Hair (Class II — Special Controls, product code OAP), submitted by Biophotas, Inc. (Anaheim, US). The FDA issued a Cleared decision on June 29, 2021, 83 days after receiving the submission on April 7, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number	K211038 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 07, 2021
Decision Date	June 29, 2021
Days to Decision	83 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OAP — Laser, Comb, Hair
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5500
Definition	Promote Hair Growth In Males With Androgenic Alopecia And Norwood Hamilton Classification Of Iia To V