Alite

Basic Information

• Brand Name: Alite
• Primary DI: 00850036790020
• Version / Model: AVE003
• Company Name: Revelle Aesthetics, Inc.
• Labeler DUNS: 117419977
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-01
• Public Version: 1
• Public Version Date: 2025-09-09
• Public Version Status: New
• Public Device Record Key: 7eac121c-aaf6-48e0-99c5-6e3bdd8b6be6

Device Description

Alite is a single-use disposable fiber-optic surgical lamp intended to provide visible illumination of the patient’s subcutaneous space as a visual aid in the delivery of solutions. Alite is only compatible with the 3.5-inch, 18 gauge needles specified in the Instructions for Use. The device consists of a Handle that houses the light delivery system and fluid pathway, the Light Fiber, male and female luer connectors, and a Pull Tab.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTD	Lamp, Surgical	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67599	Subcutaneous infusion transilluminator	An electrically-powered, hand-held device with a built-in fibreoptic light source and an invasive, rigid, light bundle intended for insertion into a hypodermic needle (not included) to percutaneously transilluminate the subcutaneous tissues to assist with needle location during infusion/injection. It additionally incorporates a fluid path, and Luer ports intended for connection of the device between the needle and an infusion/injection device (e.g., syringe, infusion pump) [not included]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850036790020	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity