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Clearflash AC2100 Cosmetic System

by Clearflash Technologies, Inc.

510(k) K111937

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 NumberK111937 Date8 Feb 2012ClearedStatusActive

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  • Withdrawn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
OLP
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

The ClearFlash AC2100 Cosmetic System is an over-the-counter powered light based laser for acne, as defined in its FDA 510(k) clearance. It is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

The device is supplied as a non-sterile, reusable system intended for use in home or clinical settings. It has received FDA 510(k) clearance under regulation number 878.4810 and product code OLP, with a decision date of February 8, 2012, and is classified as a Class II medical device.

Questions

AI-generated answers, 27 Sep 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 ClearFlash AC2100 Cosmetic System used for?

    The ClearFlash AC2100 Cosmetic System is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne. It functions as an over-the-counter powered light-based laser device designed to target acne lesions topically.

  • Is the ClearFlash AC2100 Cosmetic System sterile or non-sterile, and is it reusable?

    The device is supplied as a non-sterile, reusable system. It is intended for multiple uses over time in either home or clinical environments, and does not require sterilization between uses as per its design and labeling.

  • What regulatory pathway was used for the ClearFlash AC2100 Cosmetic System?

    The ClearFlash AC2100 Cosmetic System received FDA 510(k) clearance, demonstrating substantial equivalence to a substantial equivalence to a legally marketed predicate device. The clearance was granted under regulation number 878.4810 and product code OLP on February 8, 2012.

  • Where can the ClearFlash AC2100 Cosmetic System be used?

    The device is intended for use in both home and clinical settings. As an over-the-counter product, it does not require professional supervision for operation, though it may also be used in clinical environments by trained individuals.

  • What is the product code and device class for the ClearFlash AC2100 Cosmetic System?

    The device is assigned product code OLP and is classified as a Class II medical device by the FDA. This classification reflects its risk level and the regulatory controls necessary to ensure its safety and effectiveness.