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Deka Lipoai M131A1

by El.en. SpA

Deka Lipoai M131A1 is a general/multiple surgical solid-state laser system (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by El.en. SpA, cleared under FDA 510(k) K212270 on 21 Oct 2021 and listed in FDA GUDID since 5 Apr 2022 (UDI-DI 08057017760580), 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) K212270

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 Number08057017760580 UDI-DI Date5 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK212270 Date21 Oct 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212270 decided 21 Oct 2021 Active
  • FDA GUDID UDI-DI 08057017760580 listed 5 Apr 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212270
  2. Listed FDA GUDID 08057017760580

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Deka Lipoai
Generic name
General/multiple surgical solid-state laser system
Model / Ref / Catalog
M131A1
Primary DI / UDI-DI
08057017760580
510(k) Number
FDA product code
GEX
GMDN term
General/multiple surgical solid-state laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: General/multiple surgical solid-state laser system

Similar devices in this category

Other devices filed under General/multiple surgical solid-state laser system.

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Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)