The following data is part of a premarket notification filed by Shaser, Inc. with the FDA for Shaser Skin Beauty Intense Pulsed Light System Family.
| Device ID | K141583 |
| 510k Number | K141583 |
| Device Name: | SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | SHASER, INC. 10 Maguire Rd Ste 120 BUILDING 1 Lexington, MA 02421 |
| Contact | Anthony Burns |
| Correspondent | Anthony Burns SHASER, INC. 10 Maguire Rd Ste 120 BUILDING 1 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 | 2014-06-13 |
| Decision Date | 2014-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10074590552567 | K141583 | 000 |
| 10074590547891 | K141583 | 000 |
| 00074590544503 | K141583 | 000 |