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Pico Shining(Pico-K) 01

by SPECLIPSE, Inc.

Pico Shining(Pico-K) 01 is a Class II device made by SPECLIPSE, Inc., cleared under FDA 510(k) K261214 on 11 May 2026 and listed in FDA GUDID since 21 May 2026 (UDI-DI 08800209800058), active as of 23 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 23 Oct 2026

Documents

510(k) K261214

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800209800058 UDI-DI Date21 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK261214 Date11 May 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K261214 decided 11 May 2026 Active
  • FDA GUDID UDI-DI 08800209800058 listed 21 May 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K261214
  2. Listed FDA GUDID 08800209800058

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pico Shining(Pico-K)
Generic name
Multi-modality skin surface treatment system generator
Model / reference
01
Primary DI / UDI-DI
08800209800058
510(k) Number
FDA product code
GEX
GMDN term
Multi-modality skin surface treatment system generator
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K261214)

Similar devices

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

Other devices from SPECLIPSE, Inc.

  • Qmode 01

    Class II

  • Picofy 01

    Class II

  • Pico Shining(Picofy) 01

    Class II

  • Pico Shining (Pico-K; Picofy)

    Class II

See all devices from SPECLIPSE, Inc. →

Properties

  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)