510(k) K240472

Device
PBM Hair Therapy Cap
Applicant
Dongguan Tutamen Metalwork Co., Ltd.
510(k) number
K240472
Product code
OAP
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-11
Date received
2024-02-20
Regulation
890.5500
Classification name
Laser, Comb, Hair
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Stephen Prior
Address
#3, Huangguotang Rd. Tangxia Town Dongguan CN 523000 523000

FDA Registration Numbers

Source Documents

510(k) summary PDF

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