LifeRay

GUDID 00860014827303

The Lucas Lifecare’s LifeRay handheld is indicated for use only by a trained and qualified dentist or dental technicians for both adult and pediatric subjects for producing diagnostic dental images using various intraoral image sensors/receptors.

Lucas Lifecare, LLC

Diagnostic x-ray system generator, hand-held

• Primary Device ID: 00860014827303
• NIH Device Record Key: 7e88fb5d-aa10-493e-93a5-274e74504c0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeRay
• Version Model Number: A0201000
• Company DUNS: 089663452
• Company Name: Lucas Lifecare, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860014827303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241305

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-12-05
• Device Publish Date: 2025-10-21

Devices Manufactured by Lucas Lifecare, LLC

• 00860014827310 - Lucas Lifecare: 2026-02-05 Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is a fully automatic tabletop steam sterilizer that uses saturated steam u
• 00860014827303 - LifeRay: 2025-12-05 The Lucas Lifecare’s LifeRay handheld is indicated for use only by a trained and qualified dentist or dental technicians for both adult and pediatric subjects for producing diagnostic dental images using various intraoral image sensors/receptors.
• 00860014827303 - LifeRay: 2025-12-05 The Lucas Lifecare’s LifeRay handheld is indicated for use only by a trained and qualified dentist or dental technicians for