ISOLED AC-POWERED LED HEADLIGHT SYSTEM
Light, Surgical, Fiberoptic
ISOLUX LLC
The following data is part of a premarket notification filed by Isolux Llc with the FDA for Isoled Ac-powered Led Headlight System.
Pre-market Notification Details
Device ID | K102266 |
510k Number | K102266 |
Device Name: | ISOLED AC-POWERED LED HEADLIGHT SYSTEM |
Classification | Light, Surgical, Fiberoptic |
Applicant | ISOLUX LLC 1045 COLLIER CENTER WAY SUITE #6 Naples, FL 34110 -8444 |
Contact | Nikolaus Andreoulakis |
Product Code | FST |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2010-08-10 |
Decision Date | 2010-09-24 |
Summary: | summary |
NIH GUDID Devices
Device Identifier | submissionNumber | Supplement |
01816835024000 |
K102266 |
000 |
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