SPECTRA305

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K820492 ↗

FDA Product Code

FTC

Device Class

Class II

Regulation

21 CFR Part 878.4630

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Ultralite HF1236 Hand and Foot System

  Class II

  FDA 510(k) K861963 Active Cleared 25 Jun 1986

• Spectra (Ultraviolet Products)

  Not classified

  FDA 510(k) K827123 Active Cleared 5 Mar 1982

• Spectra 305/350

  Class II

  FDA 510(k) K820280 Active Cleared 5 Mar 1982

• Ultralite Panelite

  Class II

  FDA 510(k) K910091 Active Cleared 30 May 1991

• Psoralite

  Class II

  FDA 510(k) K761179 Active Cleared 3 May 1977

• What is the Spectra305 used for in medical settings?

  The Spectra305 is a dermatological ultraviolet light device designed specifically for medical use in procedures related to general and plastic surgery. It employs ultraviolet radiation for targeted dermatological applications, such as phototherapy or other controlled light-based treatments. Its regulatory classification under FDA’s Light, Ultraviolet, Dermatological category confirms its intended use in clinical environments.

• Is the Spectra305 a single-use or reusable device?

  The Spectra305 is supplied as a reusable medical instrument. Unlike single-use devices, it is intended for repeated use in controlled clinical settings, provided it undergoes proper cleaning, maintenance, and sterilization protocols between procedures. Reusability is common for Class II devices like this one, balancing cost efficiency with regulatory oversight.

• What regulatory pathway does the Spectra305 follow?

  The Spectra305 was cleared through the FDA’s 510(k) process, specifically under clearance number K820492. It was determined to be substantially equivalent (SESE) to a predicate device in 1982, falling under product code FTC. This classification reflects its moderate risk level as a Class II device, requiring regulatory review to ensure safety and effectiveness in dermatological applications.

• Are there specific storage requirements for the Spectra305?

  The available regulatory records do not provide explicit details on storage conditions for the Spectra305. However, as a reusable medical device, it should be stored in a clean, dry environment protected from physical damage, extreme temperatures, and direct sunlight. Proper maintenance and calibration are also critical to ensure consistent performance and safety during use.

• Does the Spectra305 have any associated sizes or models?

  The provided data does not specify distinct sizes or model variants for the Spectra305 beyond its base designation as a dermatological ultraviolet light device. The regulatory records reference multiple registration numbers, but these pertain to administrative tracking rather than physical variations. For precise specifications, consult the manufacturer’s technical documentation or support.