510(k) K871237

SUN CAPSULE I & II SUNTANNING BOOTH by Sun Capsule, Inc. — Product Code FTC

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 April 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 at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1987
Date Received
March 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