The following data is part of a premarket notification filed by Azena Medical, Llc with the FDA for Elumi 810 + 980 Soft Tissue Laser.
| Device ID | K152032 |
| 510k Number | K152032 |
| Device Name: | ELUMI 810 + 980 Soft Tissue Laser |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AZENA MEDICAL, LLC 21 MASSOLO DR., F12 UNIT C Pleasant Hill, CA 94523 |
| Contact | Alex Di Sessa |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-07-22 |
| Decision Date | 2015-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861407000303 | K152032 | 000 |