510(k) K241881

IPL Hair Removal Device (JM-843, JM-865, JM-638) by Shenzhen Junmei Technology Co., Ltd. — Product Code OHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2024
Date Received
June 28, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Over-The-Counter Hair Removal
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

Over-the-counter device uses thermal energy to kill hair follicles for hair removal.