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CoolView

by Cutera, Inc. 2 variants

CoolView is a Class II device made by Cutera, Inc., cleared under FDA 510(k) K132185 on 6 Dec 2013 and listed in FDA GUDID since 15 Jul 2019 (UDI-DI 00816722022325), active as of 21 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 21 Oct 2026

Documents

510(k) K132185

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816722022325 UDI-DI Date15 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132185 Date6 Dec 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132185 decided 6 Dec 2013 Active
  • FDA GUDID UDI-DI 00816722022325 listed 15 Jul 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132185
  2. Listed FDA GUDID 00816722022325

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Dermatological frequency-doubled solid-state laser system
Model / reference
CoolView
Primary DI / UDI-DI
00816722022325
510(k) Number
FDA product code
GEX
GMDN term
Dermatological frequency-doubled solid-state laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dermatological frequency-doubled solid-state laser system

Cleared under the same submission (K132185)

Similar devices in this category

Other devices filed under Dermatological frequency-doubled solid-state laser system.

Other devices from Cutera, Inc.

  • truSculpt iD

    Class II

  • Titan V

    Class II

  • AviClear

    Class II

  • Solera Opus

    Class II

See all devices from Cutera, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)