510(k) K864380
K864380 is an FDA 510(k) premarket notification submitted by Luxtec Corp. for the device "LUTEX HEADLIGHT SYSTEMS". The FDA issued a decision of Substantially Equivalent on November 19, 1986. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Luxtec Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 1986
- Date Received
- November 5, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Fiberoptic
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type