Device
Optical Light Source: Fiberoptic Illuminator, Gen 2, Green iLumin series of revisions
Manufacturer
Nova Eye, Inc.
Nova Eye, Inc.
Model: FI-201
Catalog: 205001
DI: 00893872001660
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-01-09
Current Version: 2026-05-28
Description
Optical Light Source: Fiberoptic Illuminator, Gen 2, Green iLumin series of revisions
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
d5ba5a13-9408-4cee-96e0-7e2135d78011
Distribution Status:
In Commercial Distribution
DUNS Number:
079755637
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00893872001660
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65935
Name: Ophthalmic procedural light source unit
Definition:
An electrically-powered, noninvasive device designed to produce light of high intensity, often called cold light, for ophthalmic examination and procedure applications. It is designed as a portable unit with controls whereby light transmission occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., fibreoptic probes and micro light-conducting ophthalmic instruments that provide intraocular illumination).
FDA Product Codes
MPA
Endoilluminator
Premarket Submissions
Submission Number:
K062259
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
-30
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
50
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
-30
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
50
Item #2 - Storage Handling Type:
Storage Environment Temperature