Hair Removal Device, Model(s): R2815-G Pro, R2815-G
Shenzhen Jianchao Intelligent Technology Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Device details
FDA 510(k) registration fields
- K number
- K232575
- Device name
- Hair Removal Device, Model(s): R2815-G Pro, R2815-G
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-08-25
- Decision date
- 2023-11-20
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- BodyFace
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Intended Use
Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Device Description
Hair Removal Device (Model: R2815-G Pro, R2815-G), is an over-the-counter, home-use and personal device for hair reduction 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. The Hair Removal Device includes two models that are R2815-G Pro, R2815-G, and their indications for use, work principle, product structure and composition, electrical structure, performance and operation are basically the same, the only difference is that the R2815-G Pro is equipped with sapphire while R2815-G is not but with a metal treatment window surface. The device is only powered by the external power adapter. The device is fitted with a skin sensor to detect appropriate skin contact, if the treatment window of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission activation is by finger switch.
Summary parsed at:2026-06-11 04:42:27 UTC
Predicate devices
2Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.
K232575 references 2 predicate/reference devices
Cited as predicate
3IPL Hair Removal Device (JM-843, JM-865, JM-638)
Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)
IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)
3 submissions cite K232575 as a predicate