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

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Product code

OHT
21 CFR 878.4810

Predicate devices

2

Cited as predicate

2

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

2

K242595 references 2 predicate/reference devices

Cited as predicate

2

2 submissions cite K242595 as a predicate