510(k) K895410

REMINGTON TANFASTIC HANDHELD TANNING WAND by Remington Products Company, LLC — Product Code FTC

K895410 is an FDA 510(k) premarket notification submitted by Remington Products Company, LLC for the device "REMINGTON TANFASTIC HANDHELD TANNING WAND". The FDA issued a decision of Substantially Equivalent on November 27, 1989. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Remington Products Company, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1989
Date Received
September 6, 1989
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