Benchmed logo
Benchmed

Intense Pulsed Light (IPL) System

Shenzhen Fansizhe Science and Technology Co., Ltd.

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

Product code OHT· 21 CFR 878.4810

View Summary PDF

Company

Shenzhen Fansizhe Science and Technology Co., Ltd.
China (CN)

Product code

OHT
21 CFR 878.4810

Predicate devices

0
Cited in this 510(k)

Cited as predicate

1
View list →

Device details

FDA 510(k) registration fields

K number
K212881
Device name
Intense Pulsed Light (IPL) System
Company
Shenzhen Fansizhe Science and Technology Co., Ltd.
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2021-09-10
Decision date
2022-04-11
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
BodyOther
Primary application
Body
Classification source
AI classified

Indications for Use

The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.

Intended Use

The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.

Summary parsed at:2026-06-11 04:30:12 UTC

Predicate devices

0

No predicate K numbers were extracted

The Summary PDF may not be parsed yet, or this submission may not cite predicate devices

Cited as predicate

1

1 submission cite K212881 as a predicate