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Picocare Family

by Wontech Co., Ltd

510(k) K181272

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK181272 Date31 Jul 2018ClearedStatusActive

Official records

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  • Withdrawn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
FDA applicant
Wontech Co., Ltd.
Device class
Class II
Regulation
21 CFR Part 878.4810
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 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 Picocare Family is a Powered Laser Surgical Instrument (Classification Name: 878.4810) designed for dermatological, surgical, and aesthetic procedures. It employs laser technology for precise tissue treatment, including applications in dermatology and plastic surgery.

This device is supplied as a reusable medical instrument and is classified under the FDA’s General and Plastic Surgery category (Product Code: GEX). It was cleared via the Special 510(k) pathway (K181272) as substantially equivalent to a predicate device, with no explicit sterility or MRI safety notes provided in the data. Storage and handling instructions are not specified in the regulatory submission.

Devices cleared under K181272

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K181272
UDI-DISize and differences
Picocare Family, Picocare450
WONTECH CO., LTD
Picocare Family, Picocare45008800022303217 —On the market

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

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