The following data is part of a premarket notification filed by Shaser, Inc. with the FDA for Lumena Fh Hair Removal System.
| Device ID | K140631 |
| 510k Number | K140631 |
| Device Name: | LUMENA FH HAIR REMOVAL SYSTEM |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | SHASER, INC. 10 Maguire Rd Ste 120 Lexington, MA 02421 |
| Contact | Anthony Burns |
| Correspondent | Anthony Burns SHASER, INC. 10 Maguire Rd Ste 120 Lexington, MA 02421 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-12 |
| Decision Date | 2014-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10074590544265 | K140631 | 000 |
| 10074590543879 | K140631 | 000 |
| 10074590543862 | K140631 | 000 |
| 10074590543138 | K140631 | 000 |
| 10074590542377 | K140631 | 000 |
| 10074590540342 | K140631 | 000 |