(255 days)
Lavieen is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (sun spots) and ephelides (freckles).
Lavieen is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 mm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. Lavieen is equipped with a 658 nm aiming beam.
The provided text is a 510(k) Summary for the Lavieen laser system. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML-based medical devices or new clinical claims, are largely not present in this document. No clinical studies were deemed necessary or performed for this device.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
This document does not specify "acceptance criteria" in the sense of predefined thresholds for clinical performance outcomes. Instead, it demonstrates substantial equivalence to predicate devices by comparing technical characteristics and intended use.
Comparison Table for Substantial Equivalence (summarized from the document):
| Feature/Parameter | Proposed Device (Lavieen) | Predicate Device #1 (LASEMD) | Predicate Device #2 (Joule System) | Substantially Equivalent (Yes/No/Comment) |
|---|---|---|---|---|
| Intended Use | Dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis, benign pigmented lesions (lentigos, solar lentigos, ephelides). | Same | Same | Yes |
| Laser Type | Thulium laser | Thulium laser | Thulium laser | Yes |
| Laser Wavelength | 1927 nm | 1927 nm | 1927 nm | Yes |
| Aiming Beam | 658 nm | 658 nm | 658 nm | Yes |
| Beam Delivery | Fiber and Handpiece | Fiber and Handpiece | Articulated Arm or Fiber optic | Yes |
| Emission Control | Foot Switch | Foot Switch | Foot Switch | Yes |
| Laser Power | 10W | 5W | 12W | Yes (within range of predicates) |
| Pulse Duration | 0.1 - 20 ms | Max 20 ms | Max 20 ms | Yes |
| Pulse Repetition Rate | 67 - 240 Hz | 43.5 - 307.7 Hz | 0 - 3,000 Hz | Yes (within range of predicates) |
| Spot Size | 300 µm | 100 µm, 200 µm | 100 – 620 µm | Yes (similar to predicate device #2) |
Reported Device Performance (from "Non-Clinical Test Summary"):
- Max output power: 10 W (This is a design specification, not a performance metric from a clinical study).
- Electrical Safety & EMC: Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1.
- Software Validation: Designed and developed according to a software development process, verified and validated.
- Biocompatibility: Handpiece Tip (ABS) in contact with intact skin for
§ 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.