ISL QC 2000
FDA 510(k) clearance K892058 · decided 1989-06-15
Clearance details
- K-number
- K892058
- Device name
- ISL QC 2000
- Applicant
- Intelligent Surgical Lasers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-29
- Decision date
- 1989-06-15
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- LXS
- Device class
- 2
- Regulation number
- 886.4392
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- San Diego, 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 |
|---|---|---|
| MICRORUPTER V (K023045) | Meridian AG | 2002-09-26 |
| PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. (K901605) | Phoenix Laser Systems, Inc. | 1990-12-13 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.