510(k) K864975
K864975 is an FDA 510(k) premarket notification submitted by Laserscope for the device "LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT)". The FDA issued a decision of Substantially Equivalent on February 25, 1987. The device falls under product code EWG (Laser, Ent Microsurgical Carbon-Dioxide), a Class II device regulated under 21 CFR 874.4500. Laserscope has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1987
- Date Received
- December 22, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Ent Microsurgical Carbon-Dioxide
- Device Class
- Class II
- Regulation Number
- 874.4500
- Review Panel
- EN
- Submission Type