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510(k) Data Aggregation
K Number
K231717Device Name
IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
Manufacturer
Foshan Jindi Electric Appliance Co.,Ltd
Date Cleared
2023-09-06
(85 days)
Product Code
OHT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Foshan Jindi Electric Appliance Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IPL Home Use Hair Removal Device is indicated for the removal of unwanted harr. 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
IPL Home Use Hair Removal Device (Models:JD-TM003, JD-TM003, JD-TM012, JD-TM016, JD-TM022),is an over-the-counter, home-use and single-person-use device for hair reduction by using 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 device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses.
The subject device includes five models. The three models of JD-TM002,JD-TM003,JD-TM012 are white , JD-TM016 has two colors of white and purple while three colors of rose gold, green and champagne for JD-TM022. Except JD-TM022, the other four models have cooling function to relieve pain of burning sensation during operation. Except JD-TM002, you can use auxiliary head to limit the spot area and get better effect with the other four models. The auxiliary head is suitable for small parts such as underarms and lips.
IPL Home Use Hair Removal Device, models: JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 have the same indication for use, performance, structure design and operation. The main difference mainly contains product appearance, size, weight, energy density , number of levels and auxiliary head. The little difference won't affect the safety and effectiveness of the device.
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