The following data is part of a premarket notification filed by Ellex Medical Pty. Ltd. with the FDA for Lumenis Selecta Duet.
| Device ID | K021550 |
| 510k Number | K021550 |
| Device Name: | LUMENIS SELECTA DUET |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Ellex Medical Pty. Ltd. 7138 SHADY OAK RD. Minneapolis, MN 55344 |
| Contact | Bill Swaim |
| Correspondent | Bill Swaim Ellex Medical Pty. Ltd. 7138 SHADY OAK RD. Minneapolis, MN 55344 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-13 |
| Decision Date | 2002-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342395000649 | K021550 | 000 |
| 09342395000588 | K021550 | 000 |