Pallas 308/311 Solid-State UV Laser System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172639 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pallas 308/311 Solid-State UV Laser System is a self-contained ultraviolet laser device designed for targeted energy delivery to skin lesions. It emits 308nm and 311nm ultraviolet B (UVB) wavelengths, intended to treat inflammatory skin conditions while minimizing exposure to surrounding healthy tissue. This system leverages solid-state laser technology to provide precise and controlled therapeutic output, distinguishing it from traditional broadband UV sources.
The device consists of a protective console housing the laser source and a handpiece connected via an articulating arm for maneuverability. Supplied as a reusable medical device, it is intended for use in clinical settings such as dermatology offices or specialized treatment centers. The system requires proper handling and maintenance to ensure safety and efficacy, adhering to FDA clearance under 510(k) number K172639. No specific sterility or MRI compatibility details are provided in the available data.
Frequently asked questions
What types of skin conditions is the Pallas 308/311 UV Laser System specifically designed to treat, and how does it differ from traditional UV therapy methods?
The Pallas 308/311 is designed for treating inflammatory skin conditions by delivering targeted 308nm and 311nm ultraviolet B (UVB) wavelengths, which help minimize exposure to healthy surrounding tissue. Unlike traditional broadband UV sources (e.g., full-spectrum lamps), this system uses solid-state laser technology to provide precise, controlled energy delivery, improving accuracy and reducing collateral damage to unaffected skin.
Is the Pallas 308/311 a single-use or reusable device, and what maintenance considerations should clinicians keep in mind?
The Pallas 308/311 is not single-use—it is classified as a reusable medical device. Since it includes a console and articulating arm handpiece, proper cleaning, calibration, and maintenance are critical to ensure consistent performance and safety. Follow manufacturer guidelines for disinfection protocols to prevent cross-contamination in clinical settings like dermatology offices or treatment centers.
What regulatory pathway was followed for FDA clearance of this device, and which advisory committee reviewed it?
The Pallas 308/311 received FDA clearance under a traditional 510(k) pathway (K172639), determined to be *substantially equivalent* to a predicate device. The review was conducted by the Skin and Soft Tissue Infections (SU) Advisory Committee under the General, Plastic Surgery product-code category (GEX), with a third-party review involved in the process.
How is the device physically structured, and what features allow for precise treatment of skin lesions?
The system consists of a protective console housing the laser source and a handpiece connected via an articulating arm, enabling flexible positioning and maneuverability. This design allows clinicians to direct the 308nm/311nm UVB laser energy with precision, targeting specific skin lesions while adapting to different anatomical areas—ideal for dermatological treatments in controlled clinical environments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF K172639-255277, LASEROPTEK, PALLAS 308/311 Solid-State UV Laser System - fda.innolitics.com, PDF Laseroptek Co., Ltd. - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172639 | Class II | Active |
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Manufacturer
- Manufacturer
- Laseroptek Co., Ltd
- FDA Applicant
- Laseroptek Co., Ltd.
Sources (1)
- FDA 510(k) K172639 24 fields · synced Sep 19, 2026