Manufacturer
Morlaser Shenzhen Co., Ltd.IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
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
- K223524
- Device name
- IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
- Company
- Morlaser Shenzhen Co., Ltd.
- 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
3IPL Hair Removal
IPL Hair Removal, Model: OBT-02
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
K223524 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K223524 as a predicate
