SYL-9000 YAG Laser

GUDID 04712826770543

LIGHTMED CORPORATION

General/multiple surgical frequency-doubled solid-state laser system

• Primary Device ID: 04712826770543
• NIH Device Record Key: 96a67026-8e14-4349-8955-3cd4a4e36bb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYL-9000 YAG Laser
• Version Model Number: YL0013
• Company DUNS: 657731175
• Company Name: LIGHTMED CORPORATION
• 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: true
• 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 Dimensions

• Weight: 28 Kilogram

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712826770543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990075

FDA Product Code

• HQF: Laser, Ophthalmic

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: 2016-09-23

On-Brand Devices [SYL-9000 YAG Laser]

• 04712826770567: YL0021
• 04712826770550: YL0019
• 04712826770543: YL0013
• 04712826770901: YL0025