(228 days)
The GentleLASE Family of Laser Systems is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. 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 regime.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
The Candela GentleLASE Family of Laser Systems contains an alexandrite laser head, which produces laser energy emitted at nominal wavelength of 755 nm. The output of the energy is then delivered to the skin through an optical fiber delivery system which also cools the surface of the skin through either air or cryogen cooling. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen. The GentleLase Pro and GentleLase Pro LE laser systems both have the same technological and performance specifications, the same indications for use, the same principles of operation, and the same energy type. The only difference between these two systems is the color of the side panels.
The provided text describes the acceptance criteria and a study for the Candela GentleLASE Family of Laser Systems, but it is a 510(k) summary for a software update for an already cleared device, not an initial clearance document. Therefore, the information typically found in an initial clearance study (like detailed performance data from a clinical trial demonstrating efficacy against a specific acceptance criterion for a medical condition) is not present.
The focus of this document is on demonstrating that a software update to an existing device (GentleLASE Pro and GentleLASE Pro LE Laser Systems) does not negatively impact its safety or effectiveness compared to its predicate device (GentleMAX Family of Laser Systems, K133283).
Here's an analysis based on the provided text, highlighting what is available and what is explicitly stated as not required or not applicable in this context.
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria in the way one might expect for a primary efficacy study (e.g., "X% reduction in hair"). Instead, the "acceptance criteria" here are implicitly tied to the device performing "according to specifications and functions as intended" after the software update, and maintaining substantial equivalence to the predicate device.
| Acceptance Criteria (Implicit for Software Update) | Reported Device Performance (after Software Update) |
|---|---|
| Device performs according to specifications. | Performance testing demonstrated that the GentleLase Pro and GentleLase Pro LE laser systems perform according to specifications. |
| Device functions as intended. | Performance testing demonstrated that the GentleLase Pro and GentleLase Pro LE laser systems function as intended. |
| Does not affect indications for use. | The modifications made to the GentleLASE Family of Laser Systems do not affect the indications for use. |
| Does not alter fundamental scientific technology. | The modifications made to the GentleLASE Family of Laser Systems do not alter the fundamental scientific technology of the device. |
| Does not affect the mode of use. | The modifications made to the GentleLASE Family of Laser Systems do not affect the mode of use. |
| No new issues of safety or effectiveness are raised. | The modifications made to the GentleLASE Family of Laser Systems raises no new issues of safety or effectiveness. |
| Maintains similar intended uses, operating principles, design aspects (spot size, wavelength, max delivered fluence) as the predicate device. | The modified GentleLASE Family of Laser Systems have the same intended uses, utilizes similar operating principles, and matches key design aspects, including similar spot size, similar wavelength and the same maximum delivered fluence as the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/not provided. The study mentioned is "software verification and validation" and "performance testing" to standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22). This typically involves engineering and functional testing of the device itself, rather than testing on a "test set" of patients or cases.
- Data Provenance: Not applicable, as this was not a clinical study on human subjects or patient data. It was technical testing of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as there was no clinical "test set" requiring ground truth establishment by experts for medical conditions. The testing was technical verification and validation of the device's functional performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as there was no clinical "test set" requiring adjudication.
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
- This is not applicable. The device is a laser system, not an AI diagnostic tool, and this submission is for a software update, not a new device clearance or an AI assistance study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. The device is a laser system which operates with human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This is not applicable. For engineering performance testing, the "ground truth" would be the device's design specifications and the requirements of the relevant IEC standards.
8. The sample size for the training set
- This is not applicable as this is a software update for a laser system, not an AI/machine learning model that typically undergoes "training."
9. How the ground truth for the training set was established
- This is not applicable for the reasons mentioned in point 8.
§ 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.