(144 days)
The Cutera Family of CoolGlide Aesthetic Lasers is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
755 nm:
The Family of CoolGlide Aesthetic Lasers is indicated for temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime. The Family of CoolGlide Aesthetic Lasers is also indicated for:
O treatment of benign pigmented lesions
O treatment of wrinkles
O photocoagulation of dermatological vascular lesions such as, but not limited to, port wine stains, hemangiomas and telangiectasias
1064 nm:
Dermatology:
The Family of CoolGlide Aesthetic Lasers is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as, but not limited to, warts, scars, striae and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café 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. Additionally, the lasers are indicated for pigmented 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 CoolGlide lasers are also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The CoolGlide lasers are indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The CoolGlide lasers are also indicated for the treatment for pseudofolliculitis barbae (FFB).
The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The intended use of the integral cooling system in the CoolGlide laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
Surgical Applications:
The lasers are indicated for the incision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
532 nm:
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)); benign pigmented lesings [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; cutaneous lesion treatment (hemostasis, color lightening, flattening, reduction of lesion size).
Optional Pulsed Light Handpiece:
For the treatment of benign pigmented lesions.
The Cutera Family of CoolGlide Aesthetic Lasers comprises a variety of laser and non-laser light sources, including single wavelength (755 nm Alexandrite, 1064 nm Nd:YAG or 532 nm Nd:YAG), multiple wavelength, pulsed light, and laser/pulsed light combination models. The Family of CoolGlide Aesthetic Lasers treats a wide range of dermatologic conditions requiring selective photothermolysis of target chromophores.
The Family of CoolGlide Aesthetic Lasers consists of a system console, permanently attached laser handpiece, footswitch, handpiece resting tree, and detachable pulsed light handpieces.
This document is a 510(k) Summary for the Cutera Family of CoolGlide Aesthetic Lasers, aiming to demonstrate substantial equivalence to predicate devices, not to prove that the device meets specific acceptance criteria through a clinical study with detailed performance metrics. The submission focuses on technical specification comparisons and indications for use.
Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert involvement, and ground truth establishment are not present in this document. The document explicitly states "Results of Clinical Study: None."
Here's a breakdown of what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with corresponding reported device performance metrics in the way one would expect from a clinical trial. Instead, it offers a "Technical Specification Comparison" against predicate devices to demonstrate equivalence, not a direct measurement against predefined acceptance thresholds for clinical efficacy.
| Feature / Metric | Family of CoolGlide Aesthetic Lasers (New Device) | Acceptance Criteria (Implicit by Predicate) | Reported Device Performance (New Device) |
|---|---|---|---|
| Wavelengths | 755 nm Alexandrite, 1064 Nd:YAG, 532 nm Nd:YAG, 500-1300 nm pulsed light | Match or be comparable to predicate devices | Aligns with predicate capabilities, offering additional wavelengths. |
| Fluence | 755 nm: 4-100 J/cm² | ||
| 1064 nm: 3-300 J/cm² | |||
| 532 nm: 1.8-42 J/cm² | |||
| 500-1300 nm: 2-65 J/cm² | Comparable range to predicate devices (e.g., Candela 755nm: 3-100 J/cm², 1064nm: 3-520 J/cm²) | Within or exceeding ranges of predicate devices. | |
| Pulse Duration | 755 nm: 3 ms | ||
| 1064 nm: 0.1-300 ms | |||
| 532 nm: 1.5-40 ms | |||
| 500-1300 nm: 0.5-100 ms | Comparable range to predicate devices (e.g., Candela 755nm: 0.25-100 ms, 1064nm: 0.25-100 ms) | Within or exceeding ranges of predicate devices. | |
| Spot Size | 755 nm: 5, 8, 10, 12, 15 and 18 mm | ||
| 1064 nm: 3, 5, 8, 10 and 12 mm | |||
| 532 nm: 2-12 mm | |||
| 500-1300 nm: 30 x 10 mm | Comparable range to predicate devices (e.g., Candela 755nm: 1.5-24 mm, 1064nm: 1.5-24 mm) | Within or exceeding ranges of predicate devices. | |
| Output Mode | Pulsed | Pulsed | Pulsed |
| Repetition Rate | 755 nm: ≤ 2 Hz and single shot | ||
| 1064 nm: ≤ 10 Hz and single shot | |||
| 532 nm: ≤ 4 Hz and single shot | |||
| 500-1300 nm: ≤ 1 Hz and single shot | Comparable range to predicate devices (e.g., Candela 755nm: ≤ 10 Hz and single shot, 1064nm: ≤ 10 Hz and single shot) | Within or comparable to ranges of predicate devices. | |
| Laser Media | Flashlamp-pumped solid state rod | Flashlamp-pumped solid state rod | Flashlamp-pumped solid state rod |
| User Interface | Push button control or LCD color touchscreen | Push button control or LCD color touchscreen | Push button control or LCD color touchscreen |
| Treatment Beam Activation | Footswitch | Footswitch or fingerswitch | Footswitch, comparable to predicate. |
| Skin Cooling | Full contact thermoelectric chiller | Air cooling or optional cryogen cooling (Candela) / Full contact thermoelectric chiller (Altus) | Uses full contact thermoelectric chiller, similar to one predicate. |
| Aiming Beam | 755 nm: 630-680 nm | ||
| 1064 nm: 630-680 nm | |||
| 532 nm: 630-680 nm | |||
| 500-1300 nm: none | Comparable to predicate devices (e.g., Candela 755nm: 635-670 nm, 1064nm: 520-550 nm) | Within or comparable to range of predicate devices. | |
| Delivery Devices | Non-sterile, reusable, cleanable | Non-sterile, reusable, cleanable | Non-sterile, reusable, cleanable |
| Optional Detachable Handpieces | Yes | Yes (Altus), Unknown (Candela) | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable and not provided. The submission states, "Results of Clinical Study: None." The assessment is based on technical specifications and comparison to predicate devices, not a clinical test set.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no clinical study defining a test set or ground truth was conducted for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical study or test set requiring adjudication was conducted.
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 and not provided. This is a laser device, not an AI-assisted diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable and not provided. This device is a physical laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable as no clinical study or ground truth establishment was conducted. The "truth" for this submission is the established performance and indications of the legally marketed predicate devices.
8. The sample size for the training set
- Not applicable and not provided. No machine learning or an algorithm requiring a training set is described in this submission.
9. How the ground truth for the training set was established
- Not applicable as no training set or ground truth for such a set was established.
Summary of the Study (as described in the document):
The "study" presented here is a technical and regulatory comparison rather than a traditional clinical study. The manufacturer, Cutera, Inc., submitted a 510(k) Premarket Notification to demonstrate that their "Family of CoolGlide Aesthetic Lasers" is substantially equivalent to two legally marketed predicate devices:
- Family of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Handpiece (K023954)
- Candela GentleMAX Family of Laser Systems (K112715)
The equivalence is based on:
- Performance Testing Results: While not detailed in this summary, the document mentions "performance testing results" in its conclusion. These likely refer to engineering and functional tests to confirm the device operates according to its specifications, rather than clinical efficacy trials.
- Comparison of Technical Specifications: A detailed table comparing wavelengths, fluence, pulse duration, spot size, output mode, repetition rate, laser media, user interface, aiming beam, delivery devices, and skin cooling methods between the new device and the predicates.
- Comparison of Intended Uses and Indications for Use: The new device's indications for use were shown to be similar to or a superset of those of the predicate devices.
Conclusion stated in the document:
"Based on performance testing results and a comparison of technical specifications, intended uses and indications for use, the Family of CoolGlide Aesthetic Lasers has been shown to be substantially equivalent to the Family of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Handpiece (K023954) and to the Candela GentleMAX Family of Laser Systems (K112715)."
§ 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.