PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.
FDA 510(k) clearance K901605 · decided 1990-12-13
Clearance details
- K-number
- K901605
- Device name
- PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.
- Applicant
- Phoenix Laser Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-05
- Decision date
- 1990-12-13
- Days to decision
- 252 days
- Clearance type
- Traditional
- Product code
- LXS
- Device class
- 2
- Regulation number
- 886.4392
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- St.Petersburg, FL, 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 |
|---|---|---|
| MICRORUPTER V (K023045) | Meridian AG | 2002-09-26 |
| MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP (K895864) | Lasag AG | 1989-12-29 |
| NIDEK MODEL YC-1200 (K893987) | Nidek, Inc. | 1989-08-18 |
| NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS (K892204) | Nidek, Inc. | 1989-06-22 |
| ISL QC 2000 (K892058) | Intelligent Surgical Lasers, Inc. | 1989-06-15 |
Recalls involving this device
No recalls on record reference this clearance.