The following data is part of a premarket notification filed by Ismart Marketing Svcs Ltd with the FDA for Facelite.
Device ID | K191629 |
510k Number | K191629 |
Device Name: | FaceLITE |
Classification | Light Based Over The Counter Wrinkle Reduction |
Applicant | iSMART Marketing Svcs Ltd 129 Green Lanes, Sutton Coldfield Birmingham, GB B735lt |
Contact | Susan D'arcy |
Correspondent | Susan D'arcy iSMART Marketing Svcs Ltd 129 Green Lanes, Sutton Coldfield Birmingham, GB B735lt |
Product Code | OHS |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-06-19 |
Decision Date | 2019-09-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05060534510395 | K191629 | 000 |
05060534510906 | K191629 | 000 |
00628011719911 | K191629 | 000 |
05060534510500 | K191629 | 000 |
00628011719515 | K191629 | 000 |
05060534510012 | K191629 | 000 |
05060534510043 | K191629 | 000 |
05060534510081 | K191629 | 000 |
05060534510098 | K191629 | 000 |
05060534510104 | K191629 | 000 |
05060534510128 | K191629 | 000 |
05060534510159 | K191629 | 000 |
05060534510166 | K191629 | 000 |
05060534510968 | K191629 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FACELITE 90321634 not registered Live/Pending |
I-SMART DEVELOPMENTS LIMITED 2020-11-16 |
FACELITE 79300247 not registered Live/Pending |
Suprema Inc. 2020-10-28 |