Manufacturer
Oriental Inspiration LimitedHee HR Mini
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
- K170269
- Device name
- Hee HR Mini
- Company
- Oriental Inspiration Limited
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-01-27
- Decision date
- 2017-05-03
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- FaceBodyLegsBikini / Brazilian
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
HEE HR Mini is an over-the-counter device intended for the removal of unwanted hair. The HEE HR Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.
Intended Use
HEE HR Mini is an over-the-counter device intended for the removal of unwanted hair. The HEE HR Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.
Device Description
w questions of safety or effectiveness. Based on
Summary parsed at:2026-06-11 04:22:31 UTC