SurgiLux™ SL-12
by Biotex, Inc.
SurgiLux SL-12 is an operating room light (FDA Class II; FDA product code FTD, Lamp, Surgical) made by Biotex, Inc., listed in FDA GUDID since 1 Jul 2019 (UDI-DI M710SL120), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM710SL120 | Date1 Jul 2019 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- SurgiLux™
- Generic name
- Operating room light
- Model / Ref / Catalog
- SL-12
- Primary DI / UDI-DI
- M710SL120
- FDA product code
- FTD
- GMDN term
- Operating room light
- Device class
- Class II
- Regulation number
- 878.4580
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices
Other devices filed under FDA product code FTD (Lamp, Surgical).
- Scintillant Surgical Light Model 2644-01-0001 by Engineered Medical Solutions Co., LLC
- S300 Series S300-22100 by DENTIS CO., LTD
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- SURGICAL COLDLIGHT, AX8 by Affiliated Hospital Products, Inc.
- ATRICURE DISSECTOR by ATRICURE, INC.
- MI-15 EXAM SURGICAL LIGHT by Medical Illumination, Inc.
- VOLISTA 400; VOLISTA 600 by Maquet S.A.S.
- HALUX IRIS EXAMINATION AND SURGICAL LAMP by Waldmann Lighting Co.
- Polaris 100/200 G16980 by Drägerwerk AG & Co. KGaA