(89 days)
The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as 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. Use on all skin types (Fitzpatrick I-VI) including tanned skin.
The Bare : 808 Laser is a microprocessor-controlled, user friendly, sealed diode laser system that produces a wavelength of 808nm with a maximum energy of 120Jcm2. The system incorporates a diode laser within each hand piece, and the energy is delivered from the hand piece directly to the desired target. The Bare: 808 Laser consists of a console, a touch screen user interface, a footswitch and 1 handpiece.
This document is a 510(k) Summary for the Bare: 808 Laser System (K193446), a device intended for permanent hair reduction.
Here's an analysis of the provided text regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that a human clinical study was not required because the device is considered substantially equivalent to predicate devices. Therefore, there is no direct table of acceptance criteria for diagnostic/performance metrics (e.g., sensitivity, specificity) derived from a clinical study for the Bare: 808 device itself.
Instead, the "Performance Data" section lists compliance with relevant IEC (International Electrotechnical Commission) standards for electrical safety and electromagnetic compatibility as the acceptance criteria for these aspects. The reported performance is that the device was tested and complied with these standards.
| Acceptance Criteria (Performance Data) | Reported Device Performance |
|---|---|
| IEC 60601-1:2005 (Third Edition) + CORR.1:2006 + CORR.2:2007 + A1:2012 (or IEC 60601-1:2012 reprint): Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance. | Complied |
| IEC 60601-1-2:2014, EN 60601-1-2:2015 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility | Complied |
| IEC 60601-2-22:2007 + A1:2012: Test for Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | Complied |
For its intended use and indications for use, the acceptance criterion implicitly is substantial equivalence to the predicate device (Soprano Ice K140009), meaning it performs as safely and effectively. The document provides a comparison table of technical specifications between the Bare: 808 and the predicate device to demonstrate this equivalence, rather than a direct performance metric.
| Characteristic | Bare : 808 (K193446) | Soprano Ice (K140009)** | Conclusion of Equivalence |
|---|---|---|---|
| Intended Use | Same as predicate | Substantially equivalent | |
| Indication for Use | Same as predicate | Substantially equivalent | |
| Wavelength (nm) | 808 | 810 | Similar |
| Laser Media | Solid State | Solid State | Similar |
| Modes | HRS, HRM | HR, SHR | Similar |
| Energy Density (Fluence) | 2-120 (HRS), 2-20 (HRM) | 2-120 (HR), 2-20 (SHR) | Similar |
| Spot Size (mm) | 14 x 14 | 12 x 10, 20 x 10 | Similar |
| Pulse Width (msec) | 15-400 (HRS), 15-266 (HRM) | 5-200 | Similar |
| Repetition Rate (Hz) | 3-10 | 3-10 | Similar |
| Delivery Devices | Nonsterile, Reusable, cleanable | Nonsterile, Reusable, cleanable | Similar |
2. Sample size used for the test set and the data provenance:
- No clinical test set was used for the K193446 submission. The document states: "A human clinical study was not required as the device is substantially equivalent to the predicate devices."
- Data provenance for a clinical test set is therefore not applicable to this submission. The performance data provided is related to engineering and safety standards compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set was required or used.
4. Adjudication method for the test set:
- Not applicable, as no clinical test set was required or 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:
- No MRMC study was done, as this device is a laser system for hair removal, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this device is a laser system, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this submission primarily relies on compliance with established international safety and performance standards (IEC) for medical electrical equipment and laser devices, as well as the technical specifications and intended use of a legally marketed predicate device to establish substantial equivalence.
8. The sample size for the training set:
- Not applicable, as this is a hardware laser device, not a machine learning algorithm that requires a training set in the typical sense. Any internal development or testing would relate to engineering validation, not an AI training set.
9. How the ground truth for the training set was established:
- Not applicable, as it's not an AI/ML device requiring a training set with established ground truth.
§ 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.