MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP
FDA 510(k) clearance K895864 · decided 1989-12-29
Clearance details
- K-number
- K895864
- Device name
- MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP
- Applicant
- Lasag AG
- Decision
- Substantially Equivalent
- Date received
- 1989-10-03
- Decision date
- 1989-12-29
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- LXS
- Device class
- 2
- Regulation number
- 886.4392
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Lasag AG
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.
| 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 |
| 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.