OptiLux LED Illuminator
FDA 510(k) clearance K163185 · decided 2016-11-21
Clearance details
- K-number
- K163185
- Device name
- OptiLux LED Illuminator
- Applicant
- Isolux, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-11-14
- Decision date
- 2016-11-21
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- HBI
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Naples, FL, US
- Third-party review
- Yes
- Expedited review
- No
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| ENDOSCOPIC FIBEROPTIC CABLE (K991208) | Isolux America | 1999-06-23 |
| LIGHTSOURCE OR ILLUMINATOR MODEL I-100 (K983277) | Cuda Products Co. | 1998-12-16 |
| LUMINOUS 150 FIBEROPTIC ILLUMINATOR (K933593) | Progressive Dynamics, Inc. | 1993-10-28 |
| S1500 XENON LIGHT SOURCE (K922837) | Endomedix | 1992-11-03 |
| NEXTEC FIBEROPTIC CABLES (K922462) | Nextec Corp. | 1992-09-21 |
| LUMINOUS 250 FIBEROPTIC ILLUMINATOR (K921866) | Progressive Dynamics, Inc. | 1992-07-08 |
| NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL (K920167) | Nextec Corp. | 1992-03-23 |
Recalls involving this device
No recalls on record reference this clearance.