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Indicated at 2940 nm for Fitzpatrick skin types I-V for coagulation, vaporization, ablation or cutting of soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology. Specifically indicated for skin resurfacing, treatment of wrinkles, and superficial skin lesions.

The LaserPeel Soft-MET Modified Erbium Laser is a compact self-contained device that delivers a beam of laser energy at an infrared wavelength of 2940 nm to the treatment site. The LaserPeel Soft-MET Modified Erbium Laser consists of four primary components:

1. A console which houses the power supply, electronics, cooling system, and liquid crystal display screen (LCD);
2. A handpiece which contains the laser cavity and optical delivery system and is connected to the console by an umbilical cord:
3. An on/off footswitch; and
4. An integrated trolley/cart.
   The LaserPeel Soft-MET Modified Erbium Laser is not battery operated, but is controlled and operated with the aid of computer software.

The provided 510(k) summary for the LaserPeel Soft-MET Modified Erbium Laser does not include any acceptance criteria or a study demonstrating the device meets such criteria.

In fact, the document explicitly states:

• Nonclinical Performance Data: None
• Clinical Performance Data: None

Therefore, I cannot populate the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The 510(k) process in this instance seemingly granted substantial equivalence based on the device's technical characteristics and intended use being similar to legally marketed predicate devices, rather than requiring new performance studies with specific acceptance criteria.

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