FSP — Loupe, Diagnostic/Surgical Class I
FDA product code FSP covers "Loupe, Diagnostic/Surgical", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FSP
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K895248 | luxtec | IMS5000 ILLUMINATED LOUPES | September 15, 1989 |
| K891895 | zinnanti surgical instruments | SURGICAL LOUPES | April 12, 1989 |
| K864386 | luxtec | LUXTEC LOUPES FOR SURGICAL VISION | November 17, 1986 |
| K861749 | keeler instruments | 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE | May 23, 1986 |