The following data is part of a premarket notification filed by Sunoptic Technologies, Llc with the FDA for Led Light Source.
| Device ID | K093792 |
| 510k Number | K093792 |
| Device Name: | LED LIGHT SOURCE |
| Classification | Light Source, Fiberoptic, Routine |
| Applicant | SUNOPTIC TECHNOLOGIES, LLC 6018 BOWDENDALE AVE. Jacksonville, FL 32216 -6042 |
| Contact | Janice G Lee |
| Correspondent | Janice G Lee SUNOPTIC TECHNOLOGIES, LLC 6018 BOWDENDALE AVE. Jacksonville, FL 32216 -6042 |
| Product Code | FCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-10 |
| Decision Date | 2010-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843059116694 | K093792 | 000 |
| 04961333240494 | K093792 | 000 |
| 04961333233977 | K093792 | 000 |
| 04961333231096 | K093792 | 000 |
| 00843059112351 | K093792 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LED LIGHT SOURCE 79200359 5243529 Live/Registered |
Maxell Holdings, Ltd. 2016-09-01 |