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E-Light Line LED Mask

by Espansione Marketing SpA

E-Light Line LED Mask is a Class II device made by Espansione Marketing SpA, cleared under FDA 510(k) K092734 on 20 Sep 2010 and listed in FDA GUDID since 6 Jun 2018 (UDI-DI 08056389700118), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K092734

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 Number08056389700118 UDI-DI Date6 Jun 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK092734 Date20 Sep 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092734 decided 20 Sep 2010 Active
  • FDA GUDID UDI-DI 08056389700118 listed 6 Jun 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092734
  2. Listed FDA GUDID 08056389700118

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
E-Light Line
Generic name
Multi-modality skin surface treatment system
Model / Ref / Catalog
LED MASK
Primary DI / UDI-DI
08056389700118
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
Not in Commercial Distribution

Related devices

Cleared under the same submission (K092734)

and 8 more cleared under K092734

Similar devices

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

Other devices from Espansione Marketing SpA

See all devices from Espansione Marketing SpA →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)