LITEPORT LP100 SURGICAL ILLUMINATOR
FDA 510(k) clearance K041621 · decided 2004-09-13
Clearance details
- K-number
- K041621
- Device name
- LITEPORT LP100 SURGICAL ILLUMINATOR
- Applicant
- Medical Vision Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-16
- Decision date
- 2004-09-13
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- FTF
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Pleasant Hill, CA, 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 |
|---|---|---|
| FLEXIBLE ILLUMINATOR 15 (K840372) | Suncoast Medical Manufacturers, Inc. | 1984-04-24 |
| FLEXIBLE ILLUMINATOR 10 (K840373) | Suncoast Medical Manufacturers, Inc. | 1984-04-24 |
| FLEXIBLE ILLUMINATOR 5 (K840371) | Suncoast Medical Manufacturers, Inc. | 1984-04-24 |
Recalls involving this device
No recalls on record reference this clearance.