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Hee HR Mini

Oriental Inspiration Limited

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

Product code OHT· 21 CFR 878.4810

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Company

Oriental Inspiration Limited
China (CN)

Product code

OHT
21 CFR 878.4810

Predicate devices

2
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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

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questions of safety or effectiveness.
Based on

Summary parsed at:2026-06-11 04:22:31 UTC

Predicate devices

2

K170269 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K170269 as a predicate