Cleared Traditional

K173729 - REVIAN RED

K173729 is the FDA 510(k) clearance for REVIAN RED by Photonmd, Inc.. It is a Class 2 General & Plastic Surgery device (product code OAP) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K173729 · Photonmd, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
84d
Days
Class 2
Risk

K173729 is an FDA 510(k) clearance for the REVIAN RED. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Photonmd, Inc. (Morrisville, US). The FDA issued a Cleared decision on February 28, 2018 after a review of 84 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 Photonmd, Inc. devices

Submission Details

510(k) Number K173729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2017
Decision Date February 28, 2018
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 K173729.
Theradome LH40
K180460 · Theradome, Inc. · May 2018
DermaScalp Laser Cap
K173846 · Dermascalp, LLC · Mar 2018
Diode Laser Cap
K173678 · Cosmo Far East Technology Limited · Feb 2018
Irradiation Aesthetic Device
K171835 · Chongqing Peninsula Medical Technology Co., Ltd. · Jan 2018
illumiflow 148 Laser Cap
K173843 · Eglobal, LLC · Jan 2018
Theradome LH80 PRO
K171775 · Theradome, Inc. · Jan 2018