INTEGRA LED SURGICAL HEADLIGHT SYSTEM
FDA 510(k) clearance K110528 · decided 2011-05-11
Clearance details
- K-number
- K110528
- Device name
- INTEGRA LED SURGICAL HEADLIGHT SYSTEM
- Applicant
- Integra LifeSciences Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-02-24
- Decision date
- 2011-05-11
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- FSR
- Device class
- 2
- Regulation number
- 886.4335
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- York, PA, 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 |
|---|---|---|
| SOLID STATE LAMP [LED] HEADLIGHT (K031549) | Welch Allyn, Inc. | 2003-08-11 |
| LED HEADLIGHT (K031548) | Welch Allyn, Inc. | 2003-08-11 |
| HEADLAMP HL2000. (K994362) | Angiolaz, Inc. | 2000-05-11 |
Recalls involving this device
No recalls on record reference this clearance.