The following data is part of a premarket notification filed by Pulsaderm Llc with the FDA for Hair Laser Headband.
| Device ID | K182501 |
| 510k Number | K182501 |
| Device Name: | Hair Laser Headband |
| Classification | Laser, Comb, Hair |
| 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 | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-12 |
| Decision Date | 2018-10-26 |
| Summary: | summary |