(30 days)
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicted on all skin types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of pigmented and vascular lesions. such as but not limited to port wine stains, hemoangioma, warts, telangiectasia, rosacea, Venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
The Candela GentleYAG Family of Laser Systems is a flashlamp-excited, Nd: YAG(Neodymium-doped Yttrium Aluminum Garnet) laser. Pulsed laser energy at a nominal wavelength of 1064 nanometers (nm) is used. This wavelength causes maximum energy absorption by the target (hair or lesion) and minimum absorption by surrounding skin structures. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target, to minimize heat transfer to surrounding tissues.
The GentleYAG consists of the following main components: a laser system console (including software and control electronics) a control and display panel a lens-coupled, user replacement optical fiber handpiece with aiming beam a footswitch or handswitch a remote interlock connector an optional cooling device
This device, the Candela GentleYAG Family of Laser Systems, is cleared through the 510(k) pathway, which establishes substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through novel clinical studies. Therefore, the provided documentation does not contain a study demonstrating the device meets acceptance criteria in the traditional sense of a performance study with defined metrics.
Instead, the submission asserts substantial equivalence based on shared technological features and indications for use with previously cleared predicate devices. The "safety and effectiveness information" section in the submission primarily certifies compliance with relevant electrical safety and laser performance standards and reiterates the substantial equivalence to predicates.
Given this context, the following information is extracted and presented as relevant, even if it doesn't directly answer all aspects of your request for a study proving acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission based on substantial equivalence, there are no specific performance acceptance criteria or a dedicated study in the document that measures the device's performance against these criteria for clinical efficacy. Instead, the "acceptance criteria" are implied by the features and standards shared with the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| Compliance with laser performance standards | "Candela Certifies that this device is in compliance with the laser performance standards required as per 21 CFR 1000.1040." |
| Compliance with electrical safety standards | "The device conforms to the UL 2601 Electrical Safety Standard and with the Harmonized Standard EN 60601-1-2, Part 2 established by the European Community." |
| No new questions of safety or effectiveness raised | "We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the GentleYAG Family of Laser Systems." and "Therefore, we do not believe that introduction of the modified GentleYAG Family of Laser Systems raises any new issues of safety or effectiveness." This is a declarative statement based on comparison to predicate devices, not an empirically demonstrated performance metric from a study. |
| Effectiveness/Functionality: | |
| Equivalent indications for use as predicate devices | The device "shares the same indications for use" as predicate devices. The listed indications include hair removal, photocoagulation of pigmented/vascular lesions, coagulation of soft tissue, treatment of benign pigmented lesions, and treatment of wrinkles. |
| Equivalent operating principles and mechanism of action as predicate devices | "shares the same operating principles, mechanism of action" as predicate devices. |
| Equivalent technological features (wavelength, pulse duration, etc.) | The device "shares similar functional features such as wavelength, pulse duration, pulse frequency, energy, spot sizes" with predicate devices. Specifics regarding expanded ranges are mentioned (expanded pulse durations, pulse frequencies, spot sizes, energy). The wavelength is 1064 nm. |
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable. The document does not describe a clinical performance study with a test set of data to demonstrate device performance. This is a 510(k) submission primarily relying on substantial equivalence to predicate devices, not new clinical performance data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable for a 510(k) based on substantial equivalence.
4. Adjudication Method for the Test Set
Not applicable for a 510(k) based on substantial equivalence.
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 a laser system, not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (laser system), not a software algorithm, and "standalone" performance in this context is demonstrated through compliance with standards and equivalence to predicates, not a separate algorithm-only performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth is established for device performance in a clinical study within this document. The "ground truth" for clearance is the regulatory determination of substantial equivalence to already cleared predicate devices, which themselves would have established their safety and effectiveness.
8. The sample size for the training set
Not applicable. This device is a laser system. No "training set" in the context of machine learning or algorithms is described.
9. How the ground truth for the training set was established
Not applicable. No "training set" or ground truth for such a set is described.
Summary of the Study that "Proves" the Device Meets Acceptance Criteria (in the context of a 510(k)):
The "study" or justification for clearance is the comparison to predicate devices. The Candela GentleYAG Family of Laser Systems is deemed substantially equivalent to several predicate devices, including older versions of the Candela GentleYAG (K010104, K0022923, K022951, K023193), Lyra I (K020021, K003765, K003147), and Altus CoolGlide Family of Lasers (K023954, K010834, K003765).
The basis for this equivalence is:
- Identical Indications for Use: The new device shares the same intended uses as the predicates.
- Similar Operating Principles and Mechanism of Action: Both the new device and the predicates are flashlamp-excited, Nd:YAG lasers operating at 1064 nm, utilizing pulsed energy for target absorption and minimal surrounding tissue absorption.
- Similar Technological Features: The submission states the device incorporates and expands upon features of the predicate devices, including expanded pulse durations, pulse frequencies, spot sizes, and energy output, while maintaining similar wavelength.
- Compliance with Standards: The device certifies compliance with laser performance standards (21 CFR 1000.1040) and electrical safety standards (UL 2601 and EN 60601-1-2).
The conclusion drawn by Candela Corporation and accepted by the FDA is that because of these similarities, "no new questions of safety or effectiveness" are raised by the introduction of the modified GentleYAG Family of Laser Systems. Therefore, its "acceptance criteria" are met by demonstrating it is as safe and effective as the legally marketed predicate devices, through a comparative analysis of its design and intended use, rather than through a de novo clinical trial with discrete performance metrics.
§ 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.