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The family of Altus Medical CoolGlide Aesthetic Lasers are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.

1064nm:
Dermatology:
The Altus Medical Aesthetic CoolGlide laser systems are intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as 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 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 CoolGlide lasers are also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

The CoolGlide lasers are also indicated for the removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB).

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 Altus CoolGlide laser handpiece is to provide cooling of the skin, 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/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laproscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.

Indications for use (532nm):
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 lesions (nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses: plaques: cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).

Family of Altus Medical CoolGlide Aesthetic Lasers are comprised of the following main components:

• a laser system console (including software and control electronics);
• a control and display panel;
• a permanently attached fiberoptic-coupled handpiece;
• a skin cooling device integrated into the handpiece;
• a footswitch (or finger-operated exposure switch (handswitch) option integrated into the handpiece)
• a remote interlock connector (disables laser when treatment room door is opened).

This document is a 510(k) Summary for the Altus Medical CoolGlide Aesthetic Lasers, which focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed performance data against specific acceptance criteria from a clinical study.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be found in the provided text.

The document primarily states that the safety and effectiveness are based on the technological identity and similar indications for use to predicate devices. It does not describe a new clinical study to establish performance against acceptance criteria for this specific submission.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria or quantitative performance metrics are provided in the document. The basis for clearance is "substantial equivalence" to predicate devices, implying that their established performance applies.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document does not describe a new test set or clinical study for this 510(k) submission. Acceptance is based on comparison to predicate devices already on the market.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. No new test set requiring expert-established ground truth is described.

4. Adjudication Method for the Test Set

Not applicable. No new test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improvement with AI vs without AI assistance

Not applicable. This is a laser device, not an AI-assisted diagnostic tool, 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 laser device, not an algorithm, and no standalone performance study is mentioned.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating safety and effectiveness implicitly refers to the established safety and efficacy profiles of the predicate devices cleared by the FDA. There is no new ground truth established for this submission.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, and the document describes its substantial equivalence to existing devices, not the training of an algorithm.

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

Not applicable. This is a medical device, and the document describes its substantial equivalence to existing devices, not the training of an algorithm.

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