Cleared Traditional

K250467 - Red Light Hair Growth Cap (LP-RJVGRW-BLK)

K250467 is an FDA 510(k) clearance for Red Light Hair Growth Cap (LP-RJVGRW-BLK), manufactured by Shenzhen Idea Light Limited. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K250467 · Shenzhen Idea Light Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
107d
Days
Class 2
Risk

K250467 is an FDA 510(k) clearance for the Red Light Hair Growth Cap (LP-RJVGRW-BLK). Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Shenzhen Idea Light Limited (Shenzhen, CN). The FDA issued a Cleared decision on June 5, 2025 after a review of 107 days - within the typical 510(k) review window.

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 Shenzhen Idea Light Limited devices

FDA 510(k) Submission Details - K250467

510(k) Number K250467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2025
Decision Date June 05, 2025
Days to Decision 107 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
8d faster than avg
Panel avg: 115d · This submission: 107d
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 K250467.
Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
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CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
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K250308 · Dongguan Boyuan Intelligent Technology Co.,Ltd · Apr 2025
FAQ™ (302)
K242747 · Foreo, Inc. · Dec 2024
GroWell BT Hair Growth System (GW10042)
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