eLight system AS52422

GUDID 07290109950150

eLight 115Vac System, Packaged with Motif

SYNERON MEDICAL LTD

Multi-modality skin surface treatment system

• Primary Device ID: 07290109950150
• NIH Device Record Key: ae5973cb-236b-40f9-8b33-1f38b5318c1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eLight system
• Version Model Number: AS52422
• Catalog Number: AS52422
• Company DUNS: 532685716
• Company Name: SYNERON MEDICAL LTD
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109950150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031489

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

On-Brand Devices [eLight system]

• 07290109951515: eLight- 100Vac Assy Packaged with Motif
• 07290109951386: eLight 115Vac System, Packaged with Motif
• 07290109950150: eLight 115Vac System, Packaged with Motif
• 07290109950143: eLight- 100Vac Assy Packaged with Motif