MERILAS 532A
FDA 510(k) clearance K072823 · decided 2007-12-14
Clearance details
- K-number
- K072823
- Device name
- MERILAS 532A
- Applicant
- Meridian AG
- Decision
- Substantially Equivalent
- Date received
- 2007-10-02
- Decision date
- 2007-12-14
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- HQF
- Device class
- 2
- Regulation number
- 886.4390
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Littleton, CO, US
- Third-party review
- No
- Expedited review
- No
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| VISULAS combi (K233911) | Carl Zeiss Meditec, AG | 2024-09-06 |
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| Eagle device (K230722) | Belkin Vision, Ltd. | 2023-12-08 |
| VISULAS green (K232051) | Carl Zeiss Meditec | 2023-10-24 |
| VISULAS yag (K230350) | Carl Zeiss Meditec, Inc. | 2023-09-22 |
| Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse (K231011) | Meridian AG | 2023-09-12 |
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 |