LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT)
FDA 510(k) clearance K864975 · decided 1987-02-25
Clearance details
- K-number
- K864975
- Device name
- LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT)
- Applicant
- Laserscope
- Decision
- Substantially Equivalent
- Date received
- 1986-12-22
- Decision date
- 1987-02-25
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- EWG
- Device class
- 2
- Regulation number
- 874.4500
- 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 |
|---|---|---|
| BENSON CCA100 (K924652) | Benson Medical Instruments Co. | 1993-04-09 |
| LASERMATIC SURGILASER MODEL 5050 (K870587) | Lasermatic OY | 1988-08-10 |
| ILLUMINA 40 CO2 LASER SYSTEM (K880427) | Cooper Lasersonics, Inc. | 1988-04-18 |
| ILLUMINA 25 CO2 LASER SYSTEM (K880428) | Cooper Lasersonics, Inc. | 1988-04-18 |
| ILLUMINA 55 CO2 LASER SYSTEM (K880429) | Cooper Lasersonics, Inc. | 1988-04-18 |
| MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT (K872710) | Directed Energy, Inc. | 1987-09-24 |
| MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH (K870840) | Directed Energy, Inc. | 1987-06-12 |
| MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE (K862866) | Directed Energy, Inc. | 1987-01-09 |
| MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE (K862865) | Directed Energy, Inc. | 1987-01-09 |
| MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) (K862150) | Directed Energy, Inc. | 1986-09-04 |
| LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER (K862005) | Laserscope | 1986-08-29 |
| MODEL 545-45 LASER FOR EAR, NOSE & THROAT (K860975) | Britt Corp., Inc. | 1986-07-18 |
Recalls involving this device
No recalls on record reference this clearance.