LUTEX HEADLIGHT SYSTEMS
FDA 510(k) clearance K864380 · decided 1986-11-19
Clearance details
- K-number
- K864380
- Device name
- LUTEX HEADLIGHT SYSTEMS
- Applicant
- Luxtec Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-05
- Decision date
- 1986-11-19
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- FST
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sturbridge, MA, US
- Third-party review
- No
- Expedited review
- No
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