510(k) K871237
K871237 is an FDA 510(k) premarket notification submitted by Sun Capsule, Inc. for the device "SUN CAPSULE I & II SUNTANNING BOOTH". The FDA issued a decision of Substantially Equivalent on Apr 23, 1987. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Sun Capsule, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 23, 1987
- Date Received
- Mar 27, 1987
- 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)