510(k) K240583

IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W) by Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. — Product Code OHT

K240583 is an FDA 510(k) premarket notification submitted by Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. for the device "IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)". The FDA issued a decision of Substantially Equivalent on June 18, 2024. The device falls under product code OHT (Light Based Over-The-Counter Hair Removal), a Class II device regulated under 21 CFR 878.4810. Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2024
Date Received
March 1, 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.