(62 days)
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:
| Feature/Characteristic | Acceptance Criteria (Predicate Device K112715) | Reported Device Performance (Modified GentleMax Pro Laser System) |
|---|---|---|
| Wavelength | 755nm/1064nm | 755nm/1064nm |
| Pulse duration | 0.25 - 300 ms | 0.25 - 100 ms |
| Maximum fluence | 53 J/cm² (ALEX), 80 J/cm² (YAG) | 53 J/cm² (ALEX), 80 J/cm² (YAG) |
| Spot size | 1.5, 3, 6, 8, 10, 12, 15, 18mm | 1.5, 3, 6, 8, 10, 12, 15, 18mm |
| Pulse repetition rate | 10 Hz, maximum | 10 Hz, maximum |
| Pulsing control | Fingerswitch or footswitch | Fingerswitch or footswitch |
| Indications for Use | Same as predicate device (detailed below) | Same as predicate device (detailed below) |
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.
§ 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.