(39 days)
The Shaser Skin Beauty Intense Pulsed Light System Family is an over-the-counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Shaser Skin Beauty Intense Pulsed Light System Family is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.
Shaser Hair Skin Beauty Intense Pulsed Light System Family devices are Over-The-Counter, Light-Based Hair Removal Systems. The family includes an AC mains powered and battery powered version of the same device. The Principle of Operation is selective photothermolysis and the Mechanism of Operation is to disable hair growth using light to preferentially heat the hair bulb. Emission activation is by finger switch. Device includes a limited life treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.
This 510(k) summary describes a new version of an Intense Pulsed Light (IPL) system for hair removal, claiming substantial equivalence to previously cleared devices. It relies on the predicate devices' performance and does not present new acceptance criteria or device performance data for hair reduction efficacy. Instead, the study focuses on user comprehension and usability for safe operation.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria for hair reduction or phototherapeutic effect are provided in this submission for the new device. The submission references the predicate devices (Shaser V-MINI 2 and Shaser Lumena FH) as having "identical performance specifications" and "the same basic design and performance characteristics related to device safety and effectiveness."
The only "performance data" presented for the new device relates to user-friendliness:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sufficient label comprehension by consumers. | Confirmed sufficient label comprehension. |
| Safe and appropriate use of the device by consumers in a simulated OTC home-use environment. | Confirmed safe and appropriate use of the device. |
2. Sample Size Used for the Test Set and Data Provenance
- Label Comprehension: 150 study subjects.
- Usability Test: 123 study subjects.
- Data Provenance: Not explicitly stated, but the context of an OTC home-use device and consumer testing suggests the data is likely prospective and collected within the United States. The inclusion of "low literacy subjects" is noted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of "experts" establishing ground truth in the traditional sense (e.g., medical experts diagnosing conditions). For a label comprehension and usability study, the "ground truth" is typically established by:
- The instructions for use (IFU): This document defines the correct understanding and safe usage of the device.
- Study facilitators/observers: These individuals (whose qualifications are not specified) would assess whether subjects understood the label correctly and used the device safely according to predetermined criteria derived from the IFU.
4. Adjudication Method for the Test Set
Not applicable. This was not a study requiring adjudication of medical outcomes or interpretations. The assessment was based on direct observation of user interaction and responses to questions about the instructions.
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 device is an IPL hair removal system, not an AI-powered diagnostic or assistive tool for human readers. 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 a physical consumer-use device, not an algorithm. The "standalone performance" of the device itself (hair removal efficacy) is presumably based on the predicate devices, but no new standalone efficacy study was presented for this specific submission. The study described focuses on the human user's interaction with the device.
7. The Type of Ground Truth Used
- For label comprehension: The correct interpretation of the instructions for use (IFU) provided with the device.
- For usability: Safe and appropriate operation of the device according to the IFU, as observed by trained study personnel.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-driven device that requires a training set. The clinical performance data described for this submission relates to human user comprehension and usability testing, not to training an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an algorithm.
§ 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.