(53 days)
IPL 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.
IPL Hair Removal Device (Models:skn001,skn005,skn002,RoseSkinCo Lumi),is an overthe-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 provided text is a 510(k) Summary for an IPL Hair Removal Device. It focuses on demonstrating substantial equivalence to a predicate device and does not contain specific details about acceptance criteria for device performance related to efficacy (e.g., hair reduction percentage) or a clinical study proving those criteria.
The "Performance Data" section (VIII) only lists non-clinical tests conducted:
- Biocompatibility Testing: Evaluating materials for skin contact (ISO 10993-5: Cytotoxicity, ISO 10993-10: Irritation and Skin Sensitization).
- Electrical Safety and EMC: Compliance with various IEC and ANSI standards (e.g., IEC 60601-1-2, ANSI AAMI ES60601-1).
- Eye Safety: Compliance with IEC 62471.
- Software Verification and Validation: Assuring software meets specifications and mitigates hazards.
- Usability: Evaluation based on FDA guidance.
The document claims "Performance data supports that the device is safe and as effective as the predicate device and reference device for its intended use" (Section VII) and concludes "it can be concluded that the subject device IPL Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate device and reference device" (Section IX). However, it does not provide the performance data that would demonstrate efficacy for hair removal or reduction to meet specific quantitative acceptance criteria by direct study results.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance (for efficacy).
- Sample size used for the test set.
- Number of experts used to establish ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or effect size.
- Standalone performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
This kind of detailed clinical study data is typically what a reviewer would look for in a full 510(k) submission, but it's often summarized or omitted from the public-facing 510(k) Summary if substantial equivalence is demonstrated primarily through technological comparison and non-clinical testing, especially for devices with well-established predicates. The "Indications for Use" section (V) defines "permanent reduction in hair regrowth" as a "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" but does not give a specific percentage for "reduction" nor does it provide study results to demonstrate this.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.