Alite

GUDID 00850036790020

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.

Revelle Aesthetics, Inc.

Subcutaneous infusion transilluminator

• Primary Device ID: 00850036790020
• NIH Device Record Key: 7eac121c-aaf6-48e0-99c5-6e3bdd8b6be6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alite
• Version Model Number: AVE003
• Company DUNS: 117419977
• Company Name: Revelle Aesthetics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850036790020 [Primary]

FDA Product Code

• FTD: Lamp, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-09
• Device Publish Date: 2025-09-01

Devices Manufactured by Revelle Aesthetics, Inc.

• 00850036790020 - Alite: 2025-09-09Alite 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.
• 00850036790020 - Alite: 2025-09-09 Alite is a single-use disposable fiber-optic surgical lamp intended to provide visible illumination of the patient’s subcutane
• 00850036790013 - Aveli: 2024-03-05
• 00850036790006 - Aveli: 2022-02-22