MICRORUPTER V
FDA 510(k) clearance K023045 · decided 2002-09-26
Clearance details
- K-number
- K023045
- Device name
- MICRORUPTER V
- Applicant
- Meridian AG
- Decision
- Substantially Equivalent
- Date received
- 2002-09-12
- Decision date
- 2002-09-26
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- LXS
- Device class
- 2
- Regulation number
- 886.4392
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Thun, Bern, CH
- Third-party review
- Yes
- 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 |
|---|---|---|
| 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 |
| ISL QC 2000 (K892058) | Intelligent Surgical Lasers, Inc. | 1989-06-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LASAG MICRORUPTOR III Q-SWITCH ND:YAG (P840012/S007) | Meridian AG | 1991-04-05 |
| LASAG TOPAZ ND:YAG LASER SYSTEM (P840012/S006) | Meridian AG | 1990-05-01 |
| MICRORUPTOR MR-2 ND:YAG LASER SYSTEM (P840012/S005) | Meridian AG | 1988-10-26 |
| MICRORUPTOR MR-2 ND:YAG LASER SYSTEM (P840012/S003) | Meridian AG | 1987-08-27 |
| MICRORUPTOR MR-2 ND:YAG LASER SYSTEM (P840012/S002) | Meridian AG | 1987-06-22 |
| MICRORUPTOR MR-2 ND:YAG LASER SYSTEM (P840012/S001) | Meridian AG | 1986-05-30 |
| MICRORUPTOR MR-2 ND:YAG LASER SYSTEM (P840012) | Meridian AG | 1986-01-31 |