TRI*STAR
FDA 510(k) clearance K930711 · decided 1993-07-30
Clearance details
- K-number
- K930711
- Device name
- TRI*STAR
- Applicant
- Light Technology Systems
- Decision
- Substantially Equivalent
- Date received
- 1993-02-11
- Decision date
- 1993-07-30
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- FSS
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Van Nuys, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS recall (Z-1101-2007) | Sunnex Inc. | 2007-07-24 |