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Pastelle

by Wontech Co., Ltd

510(k) K250165

Pastelle is a Class II device made by Wontech Co., Ltd, cleared under FDA 510(k) K250165 on 3 Jul 2025, active as of 22 Oct 2026.

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 · Traditional NumberK250165 Date3 Jul 2025ClearedStatusActive

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  • Withdrawn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

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

Devices cleared under K250165

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 K250165
UDI-DISize and differences
Pastelle
WONTECH CO., LTD
Pastelle08800022300803 —On the market

Similar devices

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

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