The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Matrix Rf Applicator.
Device ID | K073572 |
510k Number | K073572 |
Device Name: | MATRIX RF APPLICATOR |
Classification | Powered Laser Surgical Instrument |
Applicant | SYNERON MEDICAL LTD. P.O. BOX 550 INDUSTRIAL ZONE Yokneam Illit, IL 20692 |
Contact | Yoni Iger |
Correspondent | Yoni Iger SYNERON MEDICAL LTD. P.O. BOX 550 INDUSTRIAL ZONE Yokneam Illit, IL 20692 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-19 |
Decision Date | 2008-09-17 |
Summary: | summary |