Manufacturer
Foshan Jindi Electric Appliance Co., Ltd.IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
Foshan Jindi Electric Appliance 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
- K231717
- Device name
- IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-06-13
- Decision date
- 2023-09-06
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyLegsBikini / BrazilianUnderarm
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
IPL Home Use Hair Removal Device 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 regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Intended Use
IPL Home Use Hair Removal Device 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 regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Device Description
Name of Device: IPL Home Use Hair Removal Device. Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022. Common or Usual Name: Light Based Over-The-Counter Hair Removal. Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Regulatory Class: II. Product Code: OHT. Regulation Number: 21 CFR 878.4810.
Summary parsed at:2026-06-11 04:40:34 UTC
Predicate devices
3—
—
Not ingested
IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32
IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02
K231717 references 3 predicate/reference devices
Cited as predicate
3IPL Hair Removal Device (YT01,YT02,YT03,YT04)
IPL Home Use Hair Removal Device (SJ15)
IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)
3 submissions cite K231717 as a predicate