NUERA

GUDID 08052049500050

BIOS SRL

Radio-frequency skin contouring system

• Primary Device ID: 08052049500050
• NIH Device Record Key: f93dc3f3-8a51-4b8c-9f55-ec702c5ccbdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NUERA
• Version Model Number: APMD130
• 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	08052049500050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151296

FDA Product Code

• PBX: Massager, Vacuum, Radio Frequency Induced Heat

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-11-30
• Device Publish Date: 2018-06-06

Devices Manufactured by BIOS SRL

• 08052049500234 - Splendor X: 2024-07-10
• 08052049500241 - Splendor X: 2024-07-10
• 08052049500258 - Splendor X: 2024-07-10
• 08052049500265 - Splendor X: 2024-07-10
• 08052049500289 - OptiPLUS: 2023-11-14
• 08052049500272 - OptiPLUS: 2023-08-31
• 08052049500227 - OptiStream: 2022-10-12
• 08052049500210 - NUERA TIGHT 1ch Paris Edition: 2022-07-14