The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Two Skin Treatment System.
| Device ID | K141507 |
| 510k Number | K141507 |
| Device Name: | TWO SKIN TREATMENT SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SYNERON MEDICAL LTD. 1835 MARKET ST, 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan SYNERON MEDICAL LTD. 1835 MARKET ST, 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-06 |
| Decision Date | 2014-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109952000 | K141507 | 000 |
| 00817495024301 | K141507 | 000 |
| 00817495024318 | K141507 | 000 |
| 00817495024325 | K141507 | 000 |
| 00817495024493 | K141507 | 000 |
| 00817495024509 | K141507 | 000 |
| 00817495025100 | K141507 | 000 |
| 00817495023779 | K141507 | 000 |
| 00817495023793 | K141507 | 000 |
| 07290109951195 | K141507 | 000 |
| 07290109950662 | K141507 | 000 |
| 07290109950709 | K141507 | 000 |
| 37290109951196 | K141507 | 000 |
| 07290109950686 | K141507 | 000 |
| 07290109950693 | K141507 | 000 |
| 07290109951584 | K141507 | 000 |
| 07290109951607 | K141507 | 000 |
| 00817495022918 | K141507 | 000 |