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Claro

by Clrs Technology Corporation 2 variants

510(k) K090744

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 NumberK090744 Date15 Apr 2010ClearedStatusActive

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  • Withdrawn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, 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 Claro is an Over-the-Counter Powered Light-Based Laser Device for Acne, classified as a Class II medical device. It is designed to target and treat individual acne pimples in individuals with mild to moderate inflammatory acne by utilizing light-based technology to reduce inflammation and promote skin healing.

This device is intended for non-invasive use in clinical or home settings and is supplied as a reusable, non-sterile system. It operates within FDA-cleared parameters under the regulatory category 878.4810 and has received 510(k) clearance (K090744) for its intended use. No MRI safety information is specified, and the device is not intended for surgical procedures or sterile environments. Multiple registration numbers (e.g., 3015646995) correspond to its authorized distribution.

Other devices from Clrs Technology Corporation

  • Claro

    Class II

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 Claro device used for?

    The Claro is an over-the-counter, powered light-based laser device designed specifically to treat individual acne pimples in individuals with mild to moderate inflammatory acne. It uses light technology to reduce inflammation and promote skin healing, making it suitable for non-invasive use in both clinical and home environments.

  • Is the Claro device reusable or single-use?

    The Claro is supplied as a reusable device. It is not intended for sterile environments or surgical procedures, so it is not designed for single-use applications. Proper cleaning and maintenance are necessary to ensure its continued effectiveness and safety.

  • Is the Claro device sterile?

    No, the Claro is classified as a non-sterile device. It is intended for use in non-invasive settings, such as clinical or home environments, where sterility is not required. Always follow manufacturer guidelines for cleaning and care to maintain hygiene.

  • What regulatory approval does the Claro device have?

    The Claro has received FDA 510(k) clearance under the classification 878.4810 for its intended use as an over-the-counter powered light-based laser device for acne. The clearance number is K090744, and it is classified as a Class II medical device.

  • Can the Claro device be used in an MRI environment?

    The Claro device does not provide any specified MRI safety information. As a result, it is not recommended for use in MRI environments unless explicitly stated otherwise by the manufacturer. Always verify compatibility with your MRI facility before use.