510(k) K041212

HOUVA 3 PHOTOTHERAPY SYSTEM by National Biological Corp. — Product Code FTC

K041212 is an FDA 510(k) premarket notification submitted by National Biological Corp. for the device "HOUVA 3 PHOTOTHERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 9, 2004. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. National Biological Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2004
Date Received
May 10, 2004
Clearance Type
Special
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