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CAPOGEN Laser Cap

by Nature, Inc.redible, Inc.

510(k) K201854

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201854 Date1 Sep 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OAP
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CAPOGEN Laser Cap CG-272 is a low-level laser therapy (LLLT) device classified as a laser comb for hair growth. It delivers photobiostimulation to the scalp via 272 visible red light-emitting diodes, each emitting at a wavelength of 650 nanometers and 5 milliwatts, to promote hair growth in both men and women.

This device is intended for non-invasive use on the scalp and is supplied as a reusable medical device. It has received FDA 510(k) clearance under the classification of Class II (OAP product code) and is regulated under 21 CFR 890.5500. The device is designed for clinical use in physical medicine settings and requires no special storage conditions beyond standard medical device care.

Other devices from Nature, Inc.redible, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CAPOGEN Laser Cap CG-272 used for?

    The CAPOGEN Laser Cap CG-272 is a low-level laser therapy (LLLT) device designed to promote hair growth in men and women. It uses 272 visible red light-emitting diodes (LEDs) emitting at 650 nanometers and 5 milliwatts each to deliver photobiostimulation to the scalp. This non-invasive treatment is intended for clinical use in physical medicine settings to target hair loss.

  • How is the CAPOGEN Laser Cap CG-272 supplied and is it reusable?

    The CAPOGEN Laser Cap CG-272 is supplied as a reusable medical device. Unlike single-use items, it is intended for repeated clinical use, provided it is maintained according to standard medical device care instructions. This design allows for consistent treatment sessions without the need for disposable replacements.

  • Does the CAPOGEN Laser Cap CG-272 require special storage conditions?

    No, the CAPOGEN Laser Cap CG-272 does not require any special storage conditions beyond those typically applied to medical devices. Standard care, such as keeping it clean and dry in a safe environment, is sufficient to maintain its functionality and ensure safe use.

  • What regulatory approval does the CAPOGEN Laser Cap CG-272 hold?

    The CAPOGEN Laser Cap CG-272 has received FDA 510(k) clearance under the classification of Class II, with the product code OAP. This clearance indicates that the device is substantially equivalent to a legally marketed predicate device and is regulated under 21 CFR 890.5500.

  • How does the CAPOGEN Laser Cap CG-272 differ from other laser combs for hair growth?

    The CAPOGEN Laser Cap CG-272 features 272 red LEDs, each emitting at a precise wavelength of 650 nanometers and 5 milliwatts, which are designed to deliver targeted photobiostimulation to the scalp. This specific configuration distinguishes it from other laser combs, which may vary in the number of LEDs, their arrangement, or the wavelength and power output, ensuring a tailored approach to hair growth stimulation.