Device
Laser Cap is a hand-held cap-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser li...
Manufacturer
Hubei YJT Intelligent Technology Group Co., Ltd.
Hubei YJT Intelligent Technology Group Co., Ltd.
Model: Hat-01
DI: 06953808300503
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
Laser Cap is a hand-held cap-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the cap covers the user’s scalp to ensure the laser light reaches the user’s scalp. Model Hat-01 contains 82 laser diodes
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
594c22b6-c1a7-4e80-98e7-98ef07880d09
Distribution Status:
In Commercial Distribution
DUNS Number:
529472637
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
06953808300503
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47417
Name: Hair growth laser device
Definition:
An electronic, portable, head-worn or hand-operated device intended to be operated by a layperson affected by scalp hair loss (i.e., receding hairline/baldness due to androgenic alopecia) to stimulate hair growth on the scalp through the application of scheduled low-level laser therapy (LLLT). The device uses individual laser diodes to direct laser light at the scalp and may include features (e.g., a comb) to separate the user's hair to allow for improved penetration of the laser light. It is intended for use in the home or a clinical setting.
FDA Product Codes
OAP
Laser, Comb, Hair
Premarket Submissions
Submission Number:
K232356
Supplement Number:
000