BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E
Summary
Sun Pharmaceutical Industries, Inc. received 510(k) clearance for BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E, a GEX device. Cleared on 2024-06-13.
Details
Source
510(k) Clearance
External ID
K241358
Action Date
2024-06-13
Status
Special
Category
device
Product Code
GEX
Product Description
BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E. Product code: GEX.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Sun Pharmaceutical Industries, Inc. has 84 FDA actions in our database, including 83 recalls and 1 clearance.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Sun Pharmaceutical Industries, Inc. have FDA actions?
Sun Pharmaceutical Industries, Inc. has 84 FDA actions in our database, including 83 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K241358" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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