(113 days)
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.
| Acceptance Criteria (based on Predicate K133283) | Reported Device Performance (Modified GentleMAX Family) |
|---|---|
| Maintain 755nm Wavelength | 755nm |
| Maintain 1064nm Wavelength | 1064nm |
| Maintain Pulse duration (0.25 - 100 ms) | 0.25 - 100 ms |
| Maintain Maximum Fluence (53 J/cm2 for ALEX, 80 J/cm2 for YAG) | 53 J/cm2 (ALEX), 80 J/cm2 (YAG) |
| Maintain Spot Sizes (1.5, 3, 6, 8, 10, 12, 15, 18mm) | 1.5, 3, 6, 8, 10, 12, 15, 18mm |
| Maintain Pulse Repetition Rate (10 Hz, maximum) | 10 Hz, maximum |
| Maintain Pulsing Control (Fingerswitch or footswitch) | Fingerswitch or footswitch |
| Same Intended Uses at 755nm and 1064nm | Identical Intended Uses for these wavelengths (e.g., hair reduction, pigmented lesions, vascular lesions, wrinkles) |
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).
| Acceptance Criteria (based on Predicate K122493) | Reported Device Performance (Modified GentleMAX Family) |
|---|---|
| 1064nm Nd:YAG Wavelength | 1064nm Nd:YAG |
| 0.3ms Pulse Duration | 0.3ms |
| 15-18 J/cm2 Fluence | 15-18 J/cm2 |
| 5mm Spot Size | 5mm |
| 2-3 Hz Repetition Rate | 2-3 Hz |
| Pulsed Output Mode | Pulsed |
| Indications for Use (Temporary increase of clear nail in onychomycosis patients) | Identical Indications for Use for onychomycosis |
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.
§ 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.