Cleared Traditional

Biophotas Celluma RESTORE (K211038) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211038 · Biophotas, Inc. · General & Plastic Surgery device
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Jun 2021
Decision
83d
Days
Class 2
Risk

K211038 is an FDA 510(k) clearance for the Biophotas Celluma RESTORE. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Biophotas, Inc. (Anaheim, US). The FDA issued a Cleared decision on June 29, 2021 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 890.5500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biophotas, Inc. devices

Submission Details

510(k) Number K211038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAP Laser, Comb, Hair
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OAP Laser, Comb, Hair

All 71
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K211038.
LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
K213447 · Shenzhen Cosbeauty Technology Co., Ltd. · Jan 2022
ID-500 iRestore Hair Growth System
K213094 · Freedom Laser Therapy, Inc. · Dec 2021
Grivamax Family of Lasers, Models 272 and 148
K211192 · Leana Orders, Inc. · Jul 2021
Hair Growth Device
K210169 · Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. · Apr 2021
LaserCap Family of Lasers 300, 224, 120 & 80
K203826 · Transdermal Cap, Inc. · Mar 2021
iHelmet Laser Comb
K202631 · Slinph Technologies Co., Ltd. · Dec 2020