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VL555 9APP7747

by Ellipse A/S

VL555 9APP7747 is a Class II device made by Ellipse A/S, cleared under FDA 510(k) K150907 on 7 Jul 2015 and listed in FDA GUDID since 16 Mar 2021 (UDI-DI 05713530000369), active as of 22 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 22 Oct 2026

Documents

510(k) K150907

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05713530000369 UDI-DI Date16 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150907 Date7 Jul 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150907 decided 7 Jul 2015 Active
  • FDA GUDID UDI-DI 05713530000369 listed 16 Mar 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K150907
  2. Listed FDA GUDID 05713530000369

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VL555
Generic name
Multi-modality skin surface treatment system
Model / reference
9APP7747
Primary DI / UDI-DI
05713530000369
510(k) Number
FDA product code
GEX
GMDN term
Multi-modality skin surface treatment system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Multi-modality skin surface treatment system.

Other devices from Ellipse A/S

See all devices from Ellipse A/S →

Properties

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