(153 days)
The MCL 29 Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and in oral and maxillofacial surgery, and ophthalmology (oculoplasty).
The MCL 29 Dermablate laser is an erbium: YAG of power at 2.94um.
This looks like a 510(k) premarket notification for a medical device, specifically a laser system for soft tissue ablation. In the context of 510(k) submissions, the “acceptance criteria” and “study that proves the device meets the acceptance criteria” often refer to the demonstration of substantial equivalence to a predicate device, rather than a clinical trial with specific performance metrics like sensitivity and specificity for an AI algorithm.
Here's an analysis based on the provided text, addressing your questions where applicable within this regulatory framework:
1. Table of Acceptance Criteria and Reported Device Performance
For 510(k) applications demonstrating substantial equivalence, the "acceptance criteria" are typically that the new device shares basic features, intended use, and similar technological characteristics with a legally marketed predicate device, and does not raise different questions of safety and effectiveness.
In this document, the "performance" is assessed by comparing the specifications and intended use of the MCL 29 Dermablate laser with two predicate devices.
| Specification | Acceptance Criteria (Similar to Predicate) | Reported Device Performance (MCL 29 Dermablate Laser) |
|---|---|---|
| Intended Use | Same or similar to predicate devices: coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery, oral and maxillofacial surgery, and ophthalmology. | Meets this criterion. The stated intended use is identical (coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral and maxillofacial surgery, and ophthalmology (oculoplasty)). |
| Type of laser | Er: YAG | Er: YAG |
| Power | Similar to predicate (e.g., within a reasonable range of 5W max or 1 J/pulse max) | 6 Watts maximum (compared to TriLase's 5W max and Multilite's 30 mJ min, 1 J max - this is presented as a comparable characteristic) |
| Wavelength | 2.94 um | 2.94 um |
| Pulse width | Similar to predicate (e.g., 300 usec, 100-400 usec) | 350 usec |
| Frequency | Similar to predicate (e.g., 5-20 Hz, 1-10 Hz) | 5-15 Hz |
| Spot size | Comparable to predicate (e.g., focusing handpiece) | 1.6mm, 3mm, 5mm |
| mJ energy | Similar to predicate (e.g., 1 J/pulse maximum, 30 mJ min, 1 J max) | 100-800 mJ |
| Beam delivery | Articulated arm | Articulated arm |
| Cooling | Internal heat exchanger | Water/air heat exchanger (presented as comparable) |
| Aiming beam | Similar to predicate (e.g., 3 mW, red helium neon, 635 nm diode |
§ 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.