Maxx Luxx LED Ahs SD2D2D2

Maxx Luxx LED Ahs SD2D2D2 is a Class II device made by Avante, cleared under FDA 510(k) K100388 on 22 Jun 2010 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00815871021609), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00815871021609 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK100388	Date22 Jun 2010Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00815871021609
FDA 510(k) database 510(k) number K100388

Across registries

2 registries list this device

FDA 510(k) K100388 decided 22 Jun 2010 Active
FDA GUDID UDI-DI 00815871021609 listed 23 Sep 2016 Listed

Timeline

2 dated events

22 Jun 2010 Cleared FDA 510(k) K100388
23 Sep 2016 Listed FDA GUDID 00815871021609

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Maxx Luxx LED
Generic name: Medical monitor/light mount
Model / reference: AHS SD2D2D2

Primary DI / UDI-DI: 00815871021609
510(k) Number: K100388
FDA product code: FST
GMDN term: Medical monitor/light mount

Device class: Class II
Regulation number: 878.4580
GUDID distribution status: In Commercial Distribution

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Properties

Serial number

Other properties (14, all answered No)