ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY
FDA 510(k) clearance K875042 · decided 1988-06-24
Clearance details
- K-number
- K875042
- Device name
- ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY
- Applicant
- Surgilase, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-07
- Decision date
- 1988-06-24
- Days to decision
- 200 days
- Clearance type
- Traditional
- Product code
- LKW
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Warwick, RI, 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 |
|---|---|---|
| MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. (K880172) | Cooper Lasersonics, Inc. | 1988-03-11 |
| 25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY (K864166) | Weck Surgical Systems | 1987-02-10 |
| MEDILAS 2 (K853580) | Endo Lase, Inc. | 1986-02-13 |
| MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL (K844440) | Cooper Lasersonics, Inc. | 1985-05-09 |
Recalls involving this device
No recalls on record reference this clearance.