Model 6/01 Uv-B Fixture
FDA 510(k) K904425 · Strato-Ray Co.
510(k) numberK904425
Submission
- Device name
- Model 6/01 Uv-B Fixture
- Applicant
- Strato-Ray Co.
Minneapolis, MN, US - Received
- September 27, 1990
- Decision date
- November 21, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTC – Light, Ultraviolet, Dermatological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4630
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Model 6/01 Uv-B Fixture cleared by the FDA?
Model 6/01 Uv-B Fixture (K904425) received a 510(k) decision of Substantially Equivalent on November 21, 1990, 55 days after the submission was received.
What is the product code of K904425?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.