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The GentleMAX Family of Laser Systems is indicated for the following at the specified wavelength:

755mm
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. 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. On all skin types (Fitzpatrick I- VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

1064nm
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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. The lasers are indicated 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, hemangioma, 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), café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, 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.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.

1064nm
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

The Candela GentleMAX Family of Laser Systems contains two separate laser heads (Alexandrite and Nd: YAG), which produce laser light outputs of 755 nm and 1064 nm. respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. 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.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focused on the GentleMAX Family of Laser Systems for its primary indications (hair reduction, pigmented lesions, wrinkles, vascular lesions) and the new indication (onychomycosis) which is the focus of this 510(k) submission:

Acceptance Criteria and Device Performance

The provided document is a 510(k) summary for the GentleMAX Family of Laser Systems, specifically regarding a modification that includes a new indication for onychomycosis. For the existing indications (hair reduction, pigmented lesions, wrinkles, vascular lesions), the submission asserts substantial equivalence to previously cleared devices. For the new onychomycosis indication, the substantial equivalence is drawn against the Cutera GenesisPlus Laser (K122493).

The "acceptance criteria" in this context are primarily based on demonstrating substantial equivalence to existing predicate devices, meaning the device performs as safely and effectively as a legally marketed device without raising new questions of safety or effectiveness. For medical devices, this is often assessed through bench testing, device specifications, and sometimes clinical data.

For the existing indications (Hair Reduction, Benign Pigmented Lesions, Wrinkles, Vascular Lesions):

The acceptance criteria are implicitly met by demonstrating that the Modified GentleMAX Family of Laser Systems maintains the same technological characteristics and intended uses as the GentleMAX Family of Laser Systems (K133283). The "reported device performance" in this context is that its performance specifications (wavelength, pulse duration, fluence, spot size, repetition rate, etc.) are identical to the predicate.

For the new indication (Temporary increase of clear nail in patients with onychomycosis at 1064nm):

The acceptance criteria are established by comparing to the Cutera GenesisPlus Laser System (K122493).

Study Information

The document explicitly states: "No clinical data was required." This is a key piece of information. The "study" proving the device meets acceptance criteria primarily relies on bench testing and the demonstration of substantial equivalence through comparison of technological characteristics and intended uses with predicate devices.

1. Sample size used for the test set and the data provenance:
* Test Set Sample Size: Not applicable. The submission states "No clinical data was required," indicating there was no clinical test set of patients or anonymized data sets from patients used for this 510(k) submission.
* Data Provenance: Not applicable for a clinical test set. The data provenance would be from internal bench testing (laboratory-generated) and comparison of specifications from the predicate devices' publicly available 510(k) information.

2. 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 used. Ground truth for device specifications would be based on engineering and manufacturing standards.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable as no clinical test set requiring expert adjudication was used.

4. 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 for dermatology, not an AI-assisted diagnostic or imaging system that would involve human readers interpreting cases.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a physical medical device, not an algorithm or software-only device. Performance is evaluated based on its physical characteristics and functionality.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "ground truth" for this submission is based on engineering specifications and performance data collected during bench testing (e.g., laser output measurements, pulse duration, fluence, spot size consistency). For the new onychomycosis indication, the ground truth for equivalence is the performance specifications of the predicate device (Cutera GenesisPlus Laser System K122493).

7. The sample size for the training set:
* Not applicable. This is a medical device clearance based on substantial equivalence and bench testing, not a machine learning or AI-driven device requiring training data.

8. How the ground truth for the training set was established:
* Not applicable as no training set was used.

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755nm
The GentleMAX 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.

1064nm
The GentleMAX Family of Laser Systems is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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. The lasers are indicated 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, hemangioma, 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), café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, 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 GentleMAX Family of Laser Systems contains two separate laser heads (Alexandrite and Nd: YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. 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.

1. Acceptance Criteria and Device Performance:

Detailed Indications for Use (both predicate and modified device):

• 755nm:
  • Temporary hair reduction.
  • Stable long-term or permanent hair reduction (defined as long-term, stable reduction in the number of hairs regrowing at 6, 9, and 12 months post-treatment) on all skin types (Fitzpatrick I-VI) including tanned skin.
  • Treatment of benign pigmented lesions.
  • Treatment of wrinkles.
  • Photocoagulation of dermatological vascular lesions (e.g., port-wine stains, hemangiomas, telangiectasias).
• 1064nm:
  • Removal of unwanted hair, stable long-term or permanent hair reduction, and treatment of PFB (defined as long-term, stable reduction in the number of hairs regrowing at 6, 9, and 12 months post-treatment) on all skin types Fitzpatrick I-VI including tanned skin.
  • Photocoagulation and hemostasis of pigmented and vascular lesions such as port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
  • Coagulation and hemostasis of soft tissue.
  • Benign pigmented lesions (e.g., lentigos, solar lentigos, café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos - significant reduction in black and/or blue-black tattoos, and plaques).
  • Indicated for pigmented lesions to reduce lesion size, for patients benefiting from aggressive treatment, and for patients not responding to other laser treatments.
  • Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
  • Treatment of wrinkles.

2. Sample Size and Data Provenance:

• Sample size for the test set: Not applicable. The submission states "No clinical data was required for these modifications." The evaluation was based on non-clinical performance data and a comparison to a predicate device.
• Data provenance: Not explicitly stated as clinical data was not required. However, the non-clinical tests (EMC, electrical safety, software verification and validation) would have been performed by the manufacturer, Candela Corporation. This indicates prospective testing of the modified device's performance against established specifications. The original predicate device's performance would be historical (retrospective) for comparison.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable for this submission. No clinical studies requiring expert ground truth were conducted for these modifications. The evaluation focused on comparing technical specifications and performance data to a predicate device, not on clinical outcomes assessed by experts.

4. Adjudication Method for the Test Set:

• Not applicable as no clinical test set requiring adjudication by experts was used. The assessment appears to be based on engineering and safety testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. The document explicitly states, "No clinical data was required for these modifications." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

6. Standalone Performance Study:

• Yes, in a non-clinical context. The "Performance Data" section indicates that "All performance testing demonstrated that the GentleMax Pro Laser System performs according to specifications and functions as intended." This refers to electromagnetic compatibility (EMC), electrical safety, and software verification and validation tests run on the device itself. This can be considered a standalone performance evaluation of the device's technical functionality, distinct from clinical efficacy.

7. Type of Ground Truth Used:

• For the non-clinical testing of the modified device, the "ground truth" was the pre-defined engineering specifications, safety standards (e.g., EMC, electrical safety), and validated software requirements.
• For the overall substantial equivalence claim, the "ground truth" or reference was the performance and safety profile of the legally marketed predicate device (K112715). The modified device was deemed substantially equivalent because its non-clinical tests confirmed it performed "as well as the predicate device" and raised no new safety or effectiveness issues.

8. Sample Size for the Training Set:

• Not applicable. This submission describes modifications to an existing laser system and relies on non-clinical testing and comparison to a predicate device, not the development or training of an AI algorithm or statistical model that would require a training set of data.

9. How Ground Truth for the Training Set Was Established:

• Not applicable, as no training set was used.

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