Manufacturer
Glan Electronics Co., Ltd.IPL Hair Removal, Model: OBT-02
Country / Region:China (CN)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K213041
- Device name
- IPL Hair Removal, Model: OBT-02
- Company
- Glan Electronics Co., Ltd.
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-09-22
- Decision date
- 2021-11-18
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyOther
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The IPL Hair Removal Device OBT-02 Version is indicated for the 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. The device is used for adults.
Intended Use
The IPL Hair Removal Device OBT-02 Version is indicated for the 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. The device is used for adults.
Device Description
IPL Hair Removal, Model: OBT-02, a small over-the-counter device, is a home-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. Permanent hair reduction is 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 regimen. Emission activation is by finger switch. Device includes IPL DEVICE, Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 220g, and the size is 150 x 75 x 45mm (H*W*D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
Summary parsed at:2026-06-11 04:29:39 UTC
Predicate devices
3—
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Not ingested
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Not ingested
IPL Salon Hair Reduction System
Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt
K213041 references 3 predicate/reference devices
Cited as predicate
6IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002
IPL Hair Removal, Model: W-1095, W-1098
Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)
IPL Hair Removal Device (SYL001AZ, SYL002AZ)
6 submissions cite K213041 as a predicate
