Cleared Traditional

K240472 - PBM Hair Therapy Cap

K240472 is an FDA 510(k) clearance for PBM Hair Therapy Cap, manufactured by Dongguan Tutamen Metalwork Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K240472 · Dongguan Tutamen Metalwork Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
234d
Days
Class 2
Risk

K240472 is an FDA 510(k) clearance for the PBM Hair Therapy Cap. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Dongguan Tutamen Metalwork Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on October 11, 2024 after a review of 234 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Dongguan Tutamen Metalwork Co., Ltd. devices

FDA 510(k) Submission Details - K240472

510(k) Number K240472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2024
Decision Date October 11, 2024
Days to Decision 234 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
119d slower than avg
Panel avg: 115d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAP Device Classification - Class 2, Special Controls

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 K240472.
HIGHERDOSE Red Light Hat (HG-120K)
K242363 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Nov 2024
Hair Growth Comb (SZ-23,SZ-23A)
K241342 · Shenzhen Nuon Medical Equipment Co., Ltd. · Nov 2024
Breo Laser Hair Growth Comb (Scalp 3L)
K242620 · Shenzhen Breo Technology Co., Ltd. · Nov 2024
Robin's Egg
K240689 · Telebrands Corporation · Sep 2024
Revian Lyte (10011)
K242441 · Revian, Inc. · Sep 2024
Bosley Booster 128 Laser Cap
K240456 · Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · May 2024