Cleared Traditional

CAPOGEN Laser Cap (K201854) - FDA 510(k) Clearance

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

K201854 · Nature, Inc.redible, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
57d
Days
Class 2
Risk

K201854 is an FDA 510(k) clearance for the CAPOGEN Laser Cap. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Nature, Inc.redible, Inc. (Wilmington, US). The FDA issued a Cleared decision on September 1, 2020 after a review of 57 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 Nature, Inc.redible, Inc. devices

Submission Details

510(k) Number K201854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2020
Decision Date September 01, 2020
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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 Consultant

Feiying Drug & Medical Consulting Technical Service Group
Gamma Zhang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K201854.
iHelmet Laser Comb
K202631 · Slinph Technologies Co., Ltd. · Dec 2020
easy Hairfull
K202983 · Y & J Bio Co., Ltd. · Dec 2020
Tricoglam Home Use
K193008 · Advihair S.R.L. · Dec 2020
LG Pra. L Derma LD Scalp Care
K200464 · Lg Electronics.Inc · Jul 2020
Hair Growth System
K200929 · Xuzhou Kernel Medical Equipment Co., Ltd. · Jun 2020
Irradiation Cosmetic Device
K192552 · Chongqing Peninsula Medical Technology Co., Ltd. · Apr 2020