Sun Pharmaceutical Industries, Inc.
Product code GEX· 21 CFR 878.4810
Product code
Predicate devices
Cited as predicate
FDA 510(k) registration fields
The BLU-U® Blue Light Photodynamic Therapy illuminator Model 4170E is intended to provide phototherapeutic light to the body. The BLU-U Model 4170E is generally indicated to treat dermatological indications. The BLU-U® Model 4170E is specifically indicated to treat moderate inflammatory acne vulgaris.
The BLU-U® Blue Light Photodynamic Therapy illuminator Model 4170E is intended to provide phototherapeutic light to the body. The BLU-U Model 4170E is generally indicated to treat dermatological indications. The BLU-U® Model 4170E is specifically indicated to treat moderate inflammatory acne vulgaris.
Summary parsed at:2026-06-01 05:28:17 UTC
No predicate K numbers were extracted
The Summary PDF may not be parsed yet, or this submission may not cite predicate devices
No later 510(k)s cite this device yet
Other submissions will appear here when they list K241358 as a predicate
