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Picofy 01

by SPECLIPSE, Inc.

Picofy 01 is a Class II device made by SPECLIPSE, Inc., cleared under FDA 510(k) K253342 on 24 Dec 2025 and listed in FDA GUDID since 9 Jan 2026 (UDI-DI 08800209800034), 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) K253342

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 Number08800209800034 UDI-DI Date9 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK253342 Date24 Dec 2025IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253342 decided 24 Dec 2025 Active
  • FDA GUDID UDI-DI 08800209800034 listed 9 Jan 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K253342
  2. Listed FDA GUDID 08800209800034

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Picofy
Generic name
Multi-modality skin surface treatment system generator
Model / reference
01
Primary DI / UDI-DI
08800209800034
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

Similar devices

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

Other devices from SPECLIPSE, Inc.

See all devices from SPECLIPSE, Inc. →

Properties

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