The following data is part of a premarket notification filed by Research Instruments Ltd. with the FDA for Saturn Active Laser System.
| Device ID | K083208 |
| 510k Number | K083208 |
| Device Name: | SATURN ACTIVE LASER SYSTEM |
| Classification | System, Assisted Reproduction Laser |
| Applicant | RESEARCH INSTRUMENTS LTD. BICKLAND INDUSTRIAL PARK Falmouth, Cornwall, GB Tr11 4ta |
| Product Code | MRX |
| CFR Regulation Number | 884.6200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-31 |
| Decision Date | 2009-08-25 |
| Summary: | summary |