Shaw Sun Systems Model 2400
FDA 510(k) K885184 · Shaw Sun Systems
510(k) numberK885184
Submission
- Device name
- Shaw Sun Systems Model 2400
- Applicant
- Shaw Sun Systems
Brookline, MO, US - Received
- December 13, 1988
- Decision date
- January 9, 1989
- 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 Shaw Sun Systems Model 2400 cleared by the FDA?
Shaw Sun Systems Model 2400 (K885184) received a 510(k) decision of Substantially Equivalent on January 9, 1989, 27 days after the submission was received.
What is the product code of K885184?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.