LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL
FDA 510(k) clearance K855146 · decided 1986-04-11
Clearance details
- K-number
- K855146
- Device name
- LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL
- Applicant
- Laserscope
- Decision
- Substantially Equivalent
- Date received
- 1985-12-24
- Decision date
- 1986-04-11
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- LMS
- Device class
- 2
- Regulation number
- 874.4490
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER (K871424) | Hgm, Inc. | 1987-07-08 |
Recalls involving this device
No recalls on record reference this clearance.