LUXTEC LOUPES FOR SURGICAL VISION
FDA 510(k) clearance K864386 · decided 1986-11-17
Clearance details
- K-number
- K864386
- Device name
- LUXTEC LOUPES FOR SURGICAL VISION
- Applicant
- Luxtec Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-05
- Decision date
- 1986-11-17
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- FSP
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sturbridge, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Luxtec Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IMS5000 ILLUMINATED LOUPES (K895248) | Luxtec Corp. | 1989-09-15 |
| SURGICAL LOUPES (K891895) | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE (K861749) | Keeler Instruments, Inc. | 1986-05-23 |
Recalls involving this device
No recalls on record reference this clearance.