Manufacturer
Sun Pharmaceutical Industries, Inc.BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E
Sun Pharmaceutical Industries, Inc.
Country / Region:United States (US)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K241358
- Device name
- BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-05-14
- Decision date
- 2024-06-13
- Submission type
- Special
- Technology type
- LED(AI inferred)
- Clinical applications
- Acne treatment
- Primary application
- Acne treatment
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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
Predicate devices
0No predicate K numbers were extracted
The Summary PDF may not be parsed yet, or this submission may not cite predicate devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K241358 as a predicate