The following data is part of a premarket notification filed by Lumenis Be, Inc. with the FDA for Selecta Duet Led, Digital Duet, Selecta Led Trio, Digital Trio Laser Systems.
| Device ID | K220877 |
| 510k Number | K220877 |
| Device Name: | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems |
| Classification | Laser, Ophthalmic |
| Applicant | Lumenis Be, Inc. 1870 South Milestone Drive Salt Lake City, UT 84104 |
| Contact | Shlomit Segman |
| Correspondent | Shlomit Segman Lumenis Be, Inc. 1870 South Milestone Drive Salt Lake City, UT 84104 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-25 |
| Decision Date | 2022-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810096330345 | K220877 | 000 |
| 00810096330024 | K220877 | 000 |
| 00810096330017 | K220877 | 000 |
| 00810096330000 | K220877 | 000 |