Search Results

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.

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.

The provided text from the FDA 510(k) summary (K231717) is for an "IPL Home Use Hair Removal Device." This device is not an AI/ML-driven diagnostic or treatment system but rather a physical device that uses intense pulsed light for hair removal.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML-based device (including expert consensus, sample sizes for training/test sets, ground truth establishment, MRMC studies, etc.) is not applicable to this specific submission.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through:

• Indications for Use Comparison: The new device has the same intended use as the predicate devices.
• Technological Characteristics Comparison: Similarities and minor differences in design, materials, and specifications are discussed, with justification that these differences do not raise new safety or effectiveness concerns.
• Performance Data (Non-Clinical):
  • Biocompatibility Testing: Confirmed compliance with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization).
  • Electrical Safety and EMC: Compliance with relevant IEC and ANSI standards (IEC 60601-1-2, ANSI AAMI ES60601-1, IEC 60601-1-11, IEC 60601-2-57).
  • Eye Safety: Compliance with IEC 62471.
  • Software Verification and Validation: Software documentation consistent with a moderate level of concern, demonstrating that requirements are met and hazards mitigated.
  • Usability: Evaluated and verified according to FDA guidance.

There is no mention of an algorithm that involves machine learning, image analysis, or any form of AI that would require a study setup involving ground truth from experts, MRMC studies, or discussions of sensitivity/specificity beyond basic device performance. The device's "performance" in this context refers to its physical output (e.g., energy density, pulse duration) and safety features, not its diagnostic or predictive accuracy.

Ask a specific question about this device