Manufacturer
Shenzhen Greatro Electronic Technology Co., Ltd.Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
Shenzhen Greatro Electronic Technology 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
- K242595
- Device name
- Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-08-30
- Decision date
- 2024-11-07
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyOther
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body 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 regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. Applicable skin types: Fitzpatrick skin types I-V.
Intended Use
Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body 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 regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Device Description
The Intense Pulse Light Therapeutic Apparatus is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. There are IPL-18 BF and IPL-18 FG two models in this application. Their work principle, intended use, structure, appearance, size, and composition are the same, with differences being product function are slight differences, but these parameters are within the.
Summary parsed at:2026-06-11 04:48:02 UTC
Predicate devices
2IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD
Intense Pulse Light Therapeutic Apparatus
K242595 references 2 predicate/reference devices
Cited as predicate
2IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002)
2 submissions cite K242595 as a predicate
