TRANSCEND
Electrosurgical, Cutting & Coagulation & Accessories
SYNERON MEDICAL LTD.
The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Transcend.
Pre-market Notification Details
| Device ID | K120510 |
| 510k Number | K120510 |
| Device Name: | TRANSCEND |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SYNERON MEDICAL LTD. INDUSTRIAL ZONE, TAVOR BUILDING, P.O.B. 550 Yokneam Illit, IL 20692 |
| Contact | Sam Wade |
| Correspondent | Sam Wade SYNERON MEDICAL LTD. INDUSTRIAL ZONE, TAVOR BUILDING, P.O.B. 550 Yokneam Illit, IL 20692 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-21 |
| Decision Date | 2013-07-19 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290109952705 | K120510 | 000 |
| 07290109950396 | K120510 | 000 |
| 37290109950434 | K120510 | 000 |
| 37290109950427 | K120510 | 000 |
| 37290109950410 | K120510 | 000 |
| 17290109952212 | K120510 | 000 |
| 17290109950430 | K120510 | 000 |
| 17290109950423 | K120510 | 000 |
| 17290109950416 | K120510 | 000 |
| 07290109950402 | K120510 | 000 |
| 07290109950419 | K120510 | 000 |
| 07290109950426 | K120510 | 000 |
| 17290109952694 | K120510 | 000 |
| 07290109952215 | K120510 | 000 |
| 07290109952031 | K120510 | 000 |
| 07290109952024 | K120510 | 000 |
| 07290109951867 | K120510 | 000 |
| 07290109951751 | K120510 | 000 |
| 07290109950808 | K120510 | 000 |
| 07290109950433 | K120510 | 000 |
| 00817495024455 | K120510 | 000 |
Trademark Results [TRANSCEND]
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