Search Results
Found 1 results
510(k) Data Aggregation
K Number
K240456Device Name
Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap
Manufacturer
PLM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC
Date Cleared
2024-05-22
(97 days)
Product Code
OAP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
PLM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bosley Booster 128 Laser Cap, Boster 162 Laser Cap, and Bosley Booster 288 Laser Cap are indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
Device Description
The Bosley Booster Family of Laser Caps are low-level laser therapy (LLLT) devices designed to promote hair growth in women and men by exposing the entire scalp to the photo-stimulation of visible, red laser diodes and LEDs at 650-nm and 5mW each. The lasers and diodes are contained inside a lightweight cap. The device is powered by an included battery pack and automatically turns off after 30 minutes. The Boster Family of Laser Caps are identical to the cleared Bosley Revitalizer 272, 164 and 96 Laser Caps with the exception of the number of included low level laser diodes (LDs) and LEDs as shown below:
1. Configuration of Models
| Model | Number of LDs | Number of LEDs |
|-------------|---------------|----------------|
| Booster 128 | 51 | 77 |
| Booster 162 | 65 | 97 |
| Booster 288 | 115 | 173 |
Ask a Question
Page 1 of 1