(86 days)
The Handheld Diode Laser for Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Handheld Diode Laser for Hair Removal is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
The Handheld Diode Laser for Hair Removal is an Over-The-Counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. The device is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime permanent hair reduction is defined as long term, stale reduction in the number of hairs regrowing when measured out of 6, 9, and 12 months after the completion of the treatment regimen.
The Handheld Diode Laser for Hair Removal is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 808nm.
Laser hair removal is based on the principles of selective photothermolysis (SPTL): a combination of the appropriate laser wavelength, pulse duration, and fluence can obtain optimal effect on a targeted tissue with minimal effect on surrounding tissue.
Wavelengths of 808 nanometers (nm) are widely used in hair removal treatment, it is selectively absorbed by melanin in the hair shaft, damaging the follicular epithelium, and further causes hair loss, while the competing chromophores (oxyhemoglobin and water) absorb less energy at these wavelengths.
The provided document is a 510(k) premarket notification for a Handheld Diode Laser for Hair Removal. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this submission.
Here's a breakdown of what can be extracted and what is explicitly stated as not applicable:
1. A table of acceptance criteria and the reported device performance
No explicit "acceptance criteria" for clinical performance are presented in the form of a table with specific thresholds. The submission's primary goal is to show equivalence to predicate devices based on technical specifications and safety standards, not to demonstrate performance against predefined clinical metrics for hair removal efficacy.
However, the safety and performance aspects are compared to established standards and predicate devices. The "Performance Comparison" table (Table 2) lists technical specifications. For safety, the device's compliance with various IEC and ISO standards is presented.
Technical Specifications Comparison (Table 2)
| Item | Proposed Device Performance (Handheld Diode Laser for Hair Removal) | Predicate Device (K120737) Performance | Predicate Device (K142845) Performance | Acceptance Criteria (Implicit: Substantial Equivalence to Predicates) |
|---|---|---|---|---|
| Laser Type | Diode Laser | Diode Laser | Diode Laser | Match predicate devices |
| Laser Classification | Class IV | Class IV | Class IV | Match predicate devices |
| Laser Wavelength | 808 nm | 810 nm | 810 nm | Substantially equivalent (808nm vs 810nm considered SE) |
| Spot Size | ∅9mm (Round) | ∅10mm (Round) | 9x9 mm | Considered substantially equivalent (see "Discussion 1") |
| Fluence | 5.5 - 21.2 J/cm² | 7-22 J/cm² | 5 - 25 J/cm² | Considered substantially equivalent (overlapping ranges, see "Discussion 2") |
| Power Supply | AC 110V/50Hz-60Hz | 100-240 V 50/60Hz | 100-240 V 50/60Hz | Substantially equivalent |
Safety and Biocompatibility (Table 3)
| Item | Proposed Device Performance | Acceptance Criteria (Compliance with Standards/PredicateEquivalence) |
|---|---|---|
| Patient Contact Materials and Biocompatibility | Sapphire in handpiece and handpiece tip (Stainless Steel) | Match predicate devices (Stainless steel and Sapphire in handpiece) |
| Cytotoxicity | No Cytotoxicity (Comply with ISO 10993-5) | Comply with ISO 10993-1 |
| Sensitization | No evidence of sensitization (Comply with ISO 10993-10) | Comply with ISO 10993-10 |
| Irritation | No evidence of irritation (Comply with ISO 10993-10) | Comply with ISO 10993-10 |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (Usability Study):
- Group 1: 13 participants (7 females, 6 males; ages 19-71 years). Included two participants with dark skin tone and one with blond hair.
- Group 2: 10 participants (5 females, 5 males; ages 19-73 years).
- Data Provenance: Not explicitly stated, but given the sponsor and correspondent's addresses (China), it's highly probable the study was conducted in China. The study appears to be prospective, observing participants as they interacted with the device and its labeling.
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)
- Ground Truth for Clinical Efficacy: Not applicable, as no clinical study was performed, and thus no clinical ground truth was established for the test set in this context.
- Ground Truth for Usability Study: The "tester" observed user interactions, recorded questions, and answered them. The qualifications of this "tester" are not provided. The ground truth here was observational data on user comprehension and ability to operate the device based on labeling.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable for clinical performance. For the usability study, there isn't a formal adjudication method described. The "tester" collected observations, and the instructional manual was revised based on user feedback. A second group was then tested to confirm improvements.
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
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not done. This device is a hair removal laser, not an diagnostic AI system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No, a standalone performance study in the context of clinical efficacy (e.g., hair reduction rates) was explicitly not done. The document states: "No clinical study is included in this submission."
However, "non-clinical tests" were conducted to verify compliance with design specifications and safety standards (e.g., IEC, ISO, electrical safety, EMC, laser safety, biological evaluation). These tests are standalone in the sense that they evaluate the device's adherence to technical requirements without human clinical involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Clinical Efficacy: Not applicable, as no clinical study was performed.
- For Usability Study: The ground truth for the usability study was the direct observation of user comprehension and their ability to properly use and clean the device based on the provided labeling (Instruction Manual Rev: V 1.02 and V 1.03). User questions and difficulties were the primary "data" for identifying areas for improvement.
8. The sample size for the training set
- Training Set (for Device Development/Optimization): Not explicitly stated. The document describes usability testing and "non clinical tests" but does not detail a "training set" in the context of machine learning or extensive data-driven model development. The development process likely involved engineering iterations rather than a formal training set as understood in AI/ML.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable as a formal "training set" with established ground truth for clinical performance or an AI model is not described in this submission. The development and verification process relied on compliance with engineering standards and usability feedback, rather than a clinical training set.
§ 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.