Identifiers
- 510(k) Number
- K172273 FDA 510(k)
- FDA Product Code
- FTC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4630 FDA 510(k)
- Regulation Number
- 878.4630 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 308nm Excimer System is an ultraviolet light system designed for use in dermatological practice. It is substantially equivalent to a predicate device and classified as a Class II medical device under product code FTC.
The system is supplied as a reusable device intended for use in general and plastic surgery settings. It has received FDA 510(k) clearance under K172273 and is regulated under 21 CFR 878.4630.
Frequently asked questions
What is the 308nm Excimer System used for?
The 308nm Excimer System is an ultraviolet light system designed for use in dermatological practice, specifically intended for use in general and plastic surgery settings as a reusable device for treating skin conditions with targeted UV light therapy.
How is the 308nm Excimer System supplied and is it reusable?
The system is supplied as a reusable device, meaning it is designed for multiple uses after proper cleaning and maintenance between treatments, and is not intended for single-use disposal.
What regulatory clearance does the 308nm Excimer System have?
The device has received FDA 510(k) clearance under submission number K172273, demonstrating it is substantially equivalent to a legally marketed predicate device, and is classified as a Class II medical device under product code FTC.
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: 308NM Excimer System, 308NM Excimer System direct from Chongqing ..., Chongqing Peninsula Medical Technology Co., Ltd., 308nm Excimer System XECL-308C, XECL-308D 308nm… - FDA.report, 308nm Excimer System (K172273) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172273 | Class II | Active |
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Manufacturer
- Manufacturer
- Chongqing Peninsula Medical Technology Co., Ltd.
Sources (1)
- FDA 510(k) K172273 24 fields · synced Oct 6, 2026