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 |
| 00628011719911 | K191629 | 000 |
| 05060534510906 | K191629 | 000 |
| 05060534510968 | K191629 | 000 |
| 05060534511002 | K191629 | 000 |
| 05060534510944 | K191629 | 000 |
| 05060534511064 | K191629 | 000 |
| 05060534510982 | K191629 | 000 |
| 05060534511163 | K191629 | 000 |
| 05060534510500 | K191629 | 000 |
| 00628011719515 | K191629 | 000 |
| 05060534510166 | K191629 | 000 |
| 05060534510159 | K191629 | 000 |
| 05060534510128 | K191629 | 000 |
| 05060534510104 | K191629 | 000 |
| 05060534510098 | K191629 | 000 |
| 05060534510081 | K191629 | 000 |
| 05060534510043 | K191629 | 000 |
| 05060534510012 | K191629 | 000 |
| 05060534511156 | 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 |