510(k) K864381
K864381 is an FDA 510(k) premarket notification submitted by Luxtec Corp. for the device "LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 9, 1986. The device falls under product code FWC (Camera, Television, Surgical, With Audio), a Class I device regulated under 21 CFR 878.4160. Luxtec Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1986
- Date Received
- November 5, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Television, Surgical, With Audio
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type