510(k) K855146
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL by
Laserscope
— Product Code LMS
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 1986
- Date Received
- December 24, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
- Device Class
- Class II
- Regulation Number
- 874.4490
- Review Panel
- EN
- Submission Type