SOLID STATE LAMP [LED] HEADLIGHT
FDA 510(k) clearance K031549 · decided 2003-08-11
Clearance details
- K-number
- K031549
- Device name
- SOLID STATE LAMP [LED] HEADLIGHT
- Applicant
- Welch Allyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-05-16
- Decision date
- 2003-08-11
- Days to decision
- 87 days
- Clearance type
- Abbreviated
- Product code
- FSR
- Device class
- 2
- Regulation number
- 886.4335
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Skaneateles Falls, NY, 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 |
|---|---|---|
| INTEGRA LED SURGICAL HEADLIGHT SYSTEM (K110528) | Integra LifeSciences Corporation | 2011-05-11 |
| 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.