(134 days)
The IPL HAIR REMOVAL Device (Model: TFDA06S) is indicated for the removal of unwanted hair under the direction of a physician, after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
IPL HAIR REMOVAL, Model: TFDA06S, a portable device, is a prescription home-use device for the permanent reduction of hair growth 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. It is a personal Light-Based Hair Removal System. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Emission activation is by finger switch. Device includes IPL DEVICE, Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 260g, and the size is 185.4 x 68.5 x 41.4mm (HWD). The device adopts the international photonic beauty IPL technology. The purpose of the light is to heat the root where the hair grows.
This document is a 510(k) Summary for an IPL Hair Removal device (Model: TFDA06S). It details the device's substantial equivalence to predicate devices, primarily through non-clinical testing. It does not involve a study proving the device meets acceptance criteria related to AI/ML performance, human reader improvement, or complex ground truth establishment as would be present in an AI/ML-driven medical device submission.
Therefore, many of the requested points are not applicable to this document. I will answer the applicable points and explicitly state when information is not present.
Acceptance Criteria and Device Performance for IPL Hair Removal Device (Model: TFDA06S)
This submission primarily relies on comparing the subject device to legally marketed predicate devices through non-clinical testing to establish substantial equivalence, rather than a clinical study demonstrating performance against specific acceptance criteria for diagnostic accuracy or human-AI interaction.
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" here are implicitly the safety and performance characteristics of the predicate devices. The "reported device performance" is the demonstration of similar characteristics and compliance with relevant safety standards.
| Acceptance Criteria (Implicit by Predicate Equivalence) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Electrical Safety (IEC 60601-1, IEC60601-1-11, IEC 60601-2-57) | Complies with IEC 60601-1, IEC60601-1-11, IEC 60601-2-57 standards |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2 standard |
| Biocompatibility (Cytotoxicity - ISO 10993-5) | Complies with ISO 10993-5:2009/(R) 2014 |
| Biocompatibility (Irritation & Skin Sensitization - ISO 10993-10) | Complies with ISO 10993-10:2010 |
| Software Verification & Validation (FDA Guidance) | Software verification and validation test according to FDA guidance satisfied |
| Wavelength (similar to predicates) | 470nm |
| Max. Fluence (similar to predicates) | Max 4.83 J/cm² (Predicates: Max 5.0 J/cm², Max 4.5 J/cm²) |
| Spot Size (similar to predicates) | 3 cm² (Predicates: 1.72 cm² or 3.02 cm², 3.0 cm²) |
| Pulse Duration (similar to predicates) | 11-12 ms (Predicates: 11-12 ms, 3 milliseconds) |
| Energy Medium (similar to predicates) | Xenon Arc Flashlamp (Same as predicates) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document states: "Clinical testing: No clinical trial is necessary in the submission." Therefore, there is no "test set" in the context of clinical data for performance evaluation as would be seen for an AI/ML device. The "testing" refers to bench testing for electrical safety, EMC, biocompatibility, and software V&V. The provenance of this bench testing data is not specified beyond being "evaluated... by lab bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As no clinical trial or AI/ML performance study was conducted, there was no need for expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of clinical accuracy for an AI/ML device. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and the specifications outlined in the referenced IEC and ISO standards.
8. The sample size for the training set
Not applicable. This device does not use an AI/ML algorithm that would require a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.