510(k) K855146
K855146 is an FDA 510(k) premarket notification submitted by Laserscope for the device "LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL". The FDA issued a decision of Substantially Equivalent on April 11, 1986. The device falls under product code LMS (Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology), a Class II device regulated under 21 CFR 874.4490. Laserscope has at least 10 other 510(k) clearances on record.
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