510(k) K853679
K853679 is an FDA 510(k) premarket notification submitted by Sunjet Manufacturer, Inc. for the device "SUNJET MODELS 240/280". The FDA issued a decision of Substantially Equivalent on Oct 1, 1985. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 1, 1985
- Date Received
- Sep 4, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Light, Ultraviolet, Dermatological
- Device Class
- Class II
- Regulation Number
- 878.4630
- Review Panel
- SU
- Submission Type
- 510(k)