Manufacturer
Shenzhen Desida Technology Co., Ltd.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
Product code
OHT
21 CFR 878.4810
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
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K221643 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K221643 as a predicate