Alisun -Type 1200, Type 1000/800 and Type 700/900
510(k) K861447
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861447 | Date13 May 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FTC
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4630
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Alisun Type 1200, Type 1000/800, and Type 700/900 are ultraviolet dermatological lights designed for medical use. Classified as a Class II device under FDA regulations (878.4630), these units emit ultraviolet radiation for dermatological applications, including skin treatments and diagnostic procedures. Their design aligns with the OpenFDA classification of 'Light, Ultraviolet, Dermatological,' indicating specialized use in plastic surgery and related fields. The devices operate within defined wavelength ranges to target specific skin conditions or treatments.
These ultraviolet dermatological lights are supplied as reusable medical devices, intended for use in clinical settings such as dermatology offices or surgical suites. They are not sterile upon delivery but are intended to be cleaned and maintained according to manufacturer guidelines. The Alisun series does not require MRI compatibility considerations, as ultraviolet light devices are not affected by magnetic fields. Each type (1200, 1000/800, 700/900) may vary in power output or application settings, but all adhere to the same regulatory framework. The devices hold FDA 510(k) clearance under the Traditional pathway, with a decision date of May 13, 1986, and are categorized under the Food and Drug Administration’s product code FTC.
Questions
AI-generated answers, 1 Oct 2026
What are the Alisun Type 1200, 1000/800, and 700/900 UV dermatological lights used for?
The Alisun UV dermatological lights are designed for medical applications in dermatology and plastic surgery, including skin treatments and diagnostic procedures. They emit ultraviolet radiation within specific wavelength ranges to target conditions such as skin disorders or pre-surgical preparations. These devices are particularly suited for controlled clinical environments where precise light exposure is required.
Are the Alisun UV lights reusable or single-use?
The Alisun UV dermatological lights are reusable medical devices. They are intended for use in clinical settings such as dermatology offices or surgical suites, where they can be cleaned and maintained according to manufacturer guidelines. Unlike single-use devices, these units are built for repeated use with proper care and sterilization protocols.
Do these devices come sterile upon delivery?
No, the Alisun UV dermatological lights are not sterile upon delivery. They are designed for reusable clinical use and must be cleaned and maintained as specified by the manufacturer before each use. Sterilization procedures should follow established medical protocols to ensure safety and efficacy.
What regulatory pathway and classification apply to the Alisun UV lights?
The Alisun UV dermatological lights are classified as Class II devices under FDA regulations (product code FTC) and hold FDA 510(k) clearance through the Traditional pathway. This classification and clearance indicate that the devices have been reviewed and deemed substantially equivalent to a predicate device already on the market, ensuring compliance with safety and performance standards for medical ultraviolet light devices.
Are there differences between the Alisun Type 1200, 1000/800, and 700/900 models?
While all Alisun models (Type 1200, 1000/800, and 700/900) share the same regulatory framework and general purpose—emitting ultraviolet radiation for dermatological applications—they may vary in power output or application settings. These differences allow clinicians to select the model best suited for specific treatment requirements, such as intensity or exposure duration, without compromising the core functionality of ultraviolet light therapy.