LUCEA LED SURGICAL LIGHT SYSTEM
FDA 510(k) clearance K113679 · decided 2012-01-12
Clearance details
- K-number
- K113679
- Device name
- LUCEA LED SURGICAL LIGHT SYSTEM
- Applicant
- Maquet S.A.S.
- Decision
- Substantially Equivalent
- Date received
- 2011-12-14
- Decision date
- 2012-01-12
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- NTN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Wayne, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARTEMIS LIGHT ENGINE (K141164) | Quest Medical Imaging | 2015-03-16 |
| ENDOLED (K133311) | Olympus Winter & Ibe GmbH | 2014-07-30 |
| CLL- V1 LIGHT SOURCE (K130819) | Olympus Winter & Ibe GmbH | 2013-06-19 |
| VIDEO SYSTEM CENTER (K122831) | Olympus Medical Systems Corp. | 2012-12-14 |
| SOPRO 281 (K103813) | Sopro | 2011-03-22 |
| LO-50 LED LIGHT SOURCE (K102167) | Fiberoptics Technology, Inc. | 2010-08-17 |
| PLS PORTABLE LIGHT SOURCE (K091829) | Optim, Inc. | 2009-07-28 |
| FSC 2 (K090601) | Schoelly Imaging, Inc. | 2009-05-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers recall (Z-0759-2024) | Getinge Usa Sales Inc | 2024-01-19 |