Cleared Traditional

K183329 - Laser Hair Therapy (FDA 510(k) Clearance)

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

K183329 · Omm Imports, Inc. D/B/A Zero Gravity · General & Plastic Surgery device
Jan 2019
Decision
47d
Days
Class 2
Risk

K183329 is an FDA 510(k) clearance for the Laser Hair Therapy. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Omm Imports, Inc. D/B/A Zero Gravity (Hallandale, US). The FDA issued a Cleared decision on January 16, 2019 after a review of 47 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.

Submission Details

510(k) Number K183329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2018
Decision Date January 16, 2019
Days to Decision 47 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 132d · This submission: 47d
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 11
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K183329.
TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A)
K253669 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Jan 2026
Hair Regrowth Cap (Model: T-119-HRC)
K253349 · Light Tree Ventures Europe B.V. · Dec 2025
Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
K252414 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Oct 2025
Hair Growth Laser Cap
K252325 · Cosmo Far East Technology Limited · Oct 2025
CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
K251017 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Jun 2025
Red Light Hair Growth Cap (LP-RJVGRW-BLK)
K250467 · Shenzhen Idea Light Limited · Jun 2025