COHERENT HOLMIUM:YAG SURGICAL LASER
FDA 510(k) clearance K902990 · decided 1990-10-02
Clearance details
- K-number
- K902990
- Device name
- COHERENT HOLMIUM:YAG SURGICAL LASER
- Applicant
- Coherent Medical Division
- Decision
- Substantially Equivalent
- Date received
- 1990-07-09
- Decision date
- 1990-10-02
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Coherent Medical Division
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S022) | Coherent Medical Division | 1989-08-29 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S021) | Coherent Medical Division | 1988-08-30 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S020) | Coherent Medical Division | 1987-12-01 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S019) | Coherent Medical Division | 1987-07-21 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S018) | Coherent Medical Division | 1987-05-19 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S017) | Coherent Medical Division | 1987-03-31 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S015) | Coherent Medical Division | 1986-12-01 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S009) | Coherent Medical Division | 1986-11-07 |