Manufacturer
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.IPL Hair Removal Device
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.
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
- K183217
- Device name
- IPL Hair Removal Device
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-11-19
- Decision date
- 2019-02-15
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- UnderarmFaceLegsOther
- Primary application
- Other
- Classification source
- AI classified
Indications for Use
The IPL Hair Removal Device (Model: TB-1755) is an Over the Counter device intended for the removal of unwanted body hair. The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse SmoothSkin Gold is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. The IPL Hair Removal Device Joy Version is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
Intended Use
The IPL Hair Removal Device (Model: TB-1755) is an Over the Counter device intended for the removal of unwanted body hair. The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse SmoothSkin Gold is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. The IPL Hair Removal Device Joy Version is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
Device Description
IPL Hair Removal Device Model: TB-1755, a small over-the-counter 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. A personal Light-Based Hair Removal System. Emission activation is by finger switch. Device includes a treatment window head, an adaptor and goggles. The size of the device is about 185 x 72.4 x 69.2mm (H x W x D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
Summary parsed at:2026-06-11 04:25:05 UTC
Predicate devices
2Cited as predicate
3IPL Hair Removal Device, model: AI01
Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S
3 submissions cite K183217 as a predicate
