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One FDA 31304

by Vydence Medical

One FDA 31304 is a Class II device made by Vydence Medical, cleared under FDA 510(k) K252753 on 24 Jan 2026 and listed in FDA GUDID since 18 Feb 2026 (UDI-DI 07898786930047), 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) K252753

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 Number07898786930047 UDI-DI Date18 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK252753 Date24 Jan 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K252753 decided 24 Jan 2026 Active
  • FDA GUDID UDI-DI 07898786930047 listed 18 Feb 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K252753
  2. Listed FDA GUDID 07898786930047

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
One FDA
Generic name
Multi-modality skin surface treatment system
Model / Ref / Catalog
31304
Primary DI / UDI-DI
07898786930047
510(k) Number
FDA product code
GEX, ONF, PDZ
GMDN term
Multi-modality skin surface treatment system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K252753)

Similar devices

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

Other devices from Vydence Medical

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    Class II

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    Class II

  • Zye Yag 25705

    Class II

  • handPICO 26378

    Class II

See all devices from Vydence Medical →

Properties

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