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System Two Les SD2CD2

by Medical Illumination International, Inc

System Two Les SD2CD2 is a Class II device made by Medical Illumination International, Inc, cleared under FDA 510(k) K100388 on 22 Jun 2010 and listed in FDA GUDID since 1 Aug 2019 (UDI-DI 00816835022038), 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) K100388

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 Number00816835022038 UDI-DI Date1 Aug 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100388 Date22 Jun 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100388 decided 22 Jun 2010 Active
  • FDA GUDID UDI-DI 00816835022038 listed 1 Aug 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100388
  2. Listed FDA GUDID 00816835022038

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
System Two Les
Generic name
Operating room light system
Model / reference
SD2CD2
Primary DI / UDI-DI
00816835022038
510(k) Number
FDA product code
FST
GMDN term
Operating room light system
Device class
Class II
Regulation number
878.4580
GUDID distribution status
In Commercial Distribution

Related devices

Category: Operating room light system

Cleared under the same submission (K100388)

and 8 more cleared under K100388

Other devices from Medical Illumination International, Inc

See all devices from Medical Illumination International, Inc →

Properties

  • Serial number
Other properties (14, all answered No)