The following data is part of a premarket notification filed by Cynosure, Inc with the FDA for Tempsure.
Device ID | K171262 |
510k Number | K171262 |
Device Name: | TempSure |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Cynosure, Inc 5 Carlisle Road Westford, MA 01886 |
Contact | Amy Tannenbaum |
Correspondent | Amy Tannenbaum Cynosure, Inc 5 Carlisle Road Westford, MA 01886 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-01 |
Decision Date | 2017-09-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841494108267 | K171262 | 000 |
00841494107505 | K171262 | 000 |
00841494107512 | K171262 | 000 |
00841494107529 | K171262 | 000 |
00841494107536 | K171262 | 000 |
00841494107543 | K171262 | 000 |
00841494107642 | K171262 | 000 |
00841494107673 | K171262 | 000 |
00841494107680 | K171262 | 000 |
00841494107697 | K171262 | 000 |
00841494107703 | K171262 | 000 |
00841494107901 | K171262 | 000 |
00841494107918 | K171262 | 000 |
10841494107908 | K171262 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TEMPSURE 98243221 not registered Live/Pending |
SMISS TECHNOLOGY CO., LTD. 2023-10-27 |
TEMPSURE 88476013 5914979 Live/Registered |
Cynosure, LLC 2019-06-17 |
TEMPSURE 87397939 5571478 Live/Registered |
CYNOSURE, LLC 2017-04-04 |
TEMPSURE 86699687 4904938 Live/Registered |
HONEYVILLE, INC. 2015-07-21 |
TEMPSURE 85527640 4325489 Live/Registered |
HONEYVILLE, INC. 2012-01-27 |