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Picore

by Bio-Med USA, Inc.

510(k) K212082

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 · Special NumberK212082 Date6 Oct 2021ClearedStatusActive

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  • Withdrawn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
GEX
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 Picore is a Q-switched laser device classified under the FDA product code GEX for general and plastic surgery applications. It is designed for pigment treatment and vascular indications, utilizing pulsed laser technology to target and remove unwanted pigmentation or vascular lesions on the skin.

Supplied as a reusable medical device, the Picore is intended for use in clinical settings by trained professionals. It is regulated under 21 CFR 878.4810 and received FDA 510(k) clearance (K212082) through the Special 510(k) pathway, with a decision date of October 6, 2021. The device is manufactured by Bio-Med USA, Inc., located in Ramsey, New Jersey.

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