Hair Removal Device (Model: IPL-D26, IPL-D19)

Shenzhen Desida Technology Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code OHT· 21 CFR 878.4810

View Summary PDF

Product code

OHT
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K221643
Device name
Hair Removal Device (Model: IPL-D26, IPL-D19)
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-06-06
Decision date
2022-10-21
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
FaceBodyLegsBikini / Brazilian
Primary application
Body
Classification source
AI classified

Indications for Use

The Hair Removal Devices (models IPL-D26 and IPL-D19) are over the counter devices intended for the removal of unwanted hair. The devices are intended for permanent reduction in hair regrowth, defined as a long‐term, stable reduction in the number of hairs re‐growing when measured at 6, 9, and 12 months after the completion of treatment regimen.

Intended Use

The Hair Removal Devices (models IPL-D26 and IPL-D19) are over the counter devices intended for the removal of unwanted hair. The devices are intended for permanent reduction in hair regrowth, defined as a long‐term, stable reduction in the number of hairs re‐growing when measured at 6, 9, and 12 months after the completion of treatment regimen.

Summary parsed at:2026-06-11 04:34:09 UTC

Predicate devices

1

K221643 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K221643 as a predicate