IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03

Morlaser Shenzhen 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

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K223524
Device name
IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-11-23
Decision date
2023-02-16
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
BodyLegsBikini / BrazilianOther
Primary application
Body
Classification source
AI classified

Indications for Use

The IPL Hair Removal is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Intended Use

The IPL Hair Removal is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Device Description

IPL Hair Removal (Models: SB01, SB01A, SB01B, SB01C, SN02, SN03), is an over-the-counter, single-person-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. Model SB01, SB01A, SB01B and SB01C are powered by lithium battery and can be charged by power adapter, while model SN02 and SN03 are only powered by power adapter. Their IPL emission activation is by finger switch. All models of IPL Hair Removal adopt irreplaceable flash window and are suitable for multiple hair removal areas, including small areas (e.g. underarms, bikini lines) and large areas (e.g. arms, legs). IPL Hair Removal contains a Xenon Arc Flashlamp and a skin sensor to detect appropriate skin contact; if the device is not in full contact with the skin, the device cannot emit the treatment light pulses.

Summary parsed at:2026-06-11 04:36:58 UTC

Predicate devices

3

K223524 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K223524 as a predicate