MICRORUPTOR MR-2 ND:YAG LASER SYSTEM
FDA premarket approval P840012/S005 · decided 1988-10-26
Approval details
- PMA number
- P840012
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MICRORUPTOR MR-2 ND:YAG LASER SYSTEM
- Generic name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- Applicant
- Meridian AG
- Date received
- 1988-10-04
- Decision date
- 1988-10-26
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LOI
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Thun, Be
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MR Q; MR Q SUPINE; MR Q SLT (K232417) | Meridian AG | 2024-01-25 |
| Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse (K231011) | Meridian AG | 2023-09-12 |
| MICRORUPTOR 6 (K160677) | Meridian AG | 2017-05-19 |
| LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) (K113390) | Meridian AG | 2012-02-14 |
| MERILAS 532A (K072823) | Meridian AG | 2007-12-14 |
| MICRORUPTER V (K023045) | Meridian AG | 2002-09-26 |