VISULAS YAG III

GUDID 04049471091373

This device will be used in ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. This device is intended for use primari

Carl Zeiss Meditec AG

Ophthalmic solid-state laser system, photodisruption

• Primary Device ID: 04049471091373
• NIH Device Record Key: 51981ab1-6ffd-4746-a992-f3b40d723ab1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISULAS YAG III
• Version Model Number: VISULAS YAG III
• Company DUNS: 314594680
• Company Name: Carl Zeiss Meditec AG
• 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: true
• 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 Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049471091373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042139

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: 2016-09-20

Devices Manufactured by Carl Zeiss Meditec AG

• 04049539066435 - TIVATO® 700: 2025-01-30
• 04049539106018 - SMARTDRAPE: 2025-01-30
• 04049539106070 - INTRABEAM SMARTDRAPE: 2025-01-30
• 04049539106094 - SMARTDRAPE: 2025-01-30
• 04049539106889 - EyeMag Smart TTL: 2025-01-30
• 04049539106896 - EyeMag Classic: 2025-01-30
• 04049471095074 - MEL 90: 2024-12-23 The Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue ac
• 04049471095111 - VISUMAX: 2024-12-23 The VISUMAX is a femtosecond laser. It generates a beam of ultra-short laser pulses which are guided through the aperture in th