Splendor X

GUDID 08052049500234

BIOS SRL

Dermatological solid-state laser system

• Primary Device ID: 08052049500234
• NIH Device Record Key: f2d28103-0661-4d85-95d0-76cf84e772f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Splendor X
• Version Model Number: Splendor X Alex+Nd:YAG
• Company DUNS: 443571203
• Company Name: BIOS SRL
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08052049500234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241407

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2024-07-10
• Device Publish Date: 2024-07-02

On-Brand Devices [Splendor X]

• 08052049500265: Splendor X Nd:YAG
• 08052049500258: Splendor X Alex2
• 08052049500241: Splendor X Alex
• 08052049500234: Splendor X Alex+Nd:YAG