510(k) K852534

ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9 by R. A. Fischer Co. Corp. — Product Code FTC

K852534 is an FDA 510(k) premarket notification submitted by R. A. Fischer Co. Corp. for the device "ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9". The FDA issued a decision of Substantially Equivalent on November 8, 1985. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. R. A. Fischer Co. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1985
Date Received
June 14, 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