The following data is part of a premarket notification filed by Pulsaderm Llc with the FDA for Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37.
| Device ID | K170111 |
| 510k Number | K170111 |
| Device Name: | Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| 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 | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-12 |
| Decision Date | 2017-05-08 |
| Summary: | summary |