The following data is part of a premarket notification filed by Pulsaderm Llc with the FDA for Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72.
| Device ID | K163329 |
| 510k Number | K163329 |
| Device Name: | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | PULSADERM LLC 12801 COMMONWEALTH DR. UNITS 2-6 Fort Myers, FL 33913 |
| Contact | Gloria Avendano |
| Correspondent | Gloria Avendano PULSADERM LLC 12801 COMMONWEALTH DR. UNITS 2-6 Fort Myers, FL 33913 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-28 |
| Decision Date | 2017-04-14 |
| Summary: | summary |