SL 220

GUDID 04049471097153

An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment. The optional SL cam 5.0 is a digital imaging solution that allows the user to take images and video sequences for documentation purposes of the anterior eye segment during slit lamp examinations.

Carl Zeiss Meditec AG

Ophthalmic examination slit lamp

• Primary Device ID: 04049471097153
• NIH Device Record Key: 5eeb1157-d4fa-42f7-9c85-24302f5dd3bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SL 220
• Version Model Number: SL 800
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Transport conditions: temperature -30°C to +70°C, rel. humidity 10% to 95%
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Transport conditions: temperature -30°C to +70°C, rel. humidity 10% to 95%
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Transport conditions: temperature -30°C to +70°C, rel. humidity 10% to 95%
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Transport conditions: temperature -30°C to +70°C, rel. humidity 10% to 95%
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Transport conditions: temperature -30°C to +70°C, rel. humidity 10% to 95%
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Transport conditions: temperature -30°C to +70°C, rel. humidity 10% to 95%
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Transport conditions: temperature -30°C to +70°C, rel. humidity 10% to 95%
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Transport conditions: temperature -30°C to +70°C, rel. humidity 10% to 95%
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Transport conditions: temperature -30°C to +70°C, rel. humidity 10% to 95%
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Transport conditions: temperature -30°C to +70°C, rel. humidity 10% to 95%
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Transport conditions: temperature -30°C to +70°C, rel. humidity 10% to 95%
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Transport conditions: temperature -30°C to +70°C, rel. humidity 10% to 95%
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Transport conditions: temperature -30°C to +70°C, rel. humidity 10% to 95%

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049471097153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162684

FDA Product Code

• HJO: Biomicroscope, Slit-Lamp, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-21
• Device Publish Date: 2026-01-13

On-Brand Devices [SL 220]

• 04049471097078: An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye
• 04049471097153: An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye