OptiStream

GUDID 08052049500227

BIOS SRL

Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system

• Primary Device ID: 08052049500227
• NIH Device Record Key: c6d519bb-1a32-435c-bf82-95c974b30859
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiStream
• Version Model Number: APMD145-1ch.US-Opti
• 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	08052049500227 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-12
• Device Publish Date: 2022-10-04

Devices Manufactured by BIOS SRL

• 08052049500289 - OptiPLUS: 2023-11-14
• 08052049500272 - OptiPLUS: 2023-08-31
• 08052049500227 - OptiStream: 2022-10-12
• 08052049500227 - OptiStream: 2022-10-12
• 08052049500210 - NUERA TIGHT 1ch Paris Edition: 2022-07-14
• 08052049500135 - FEMINESS tip: 2021-11-10
• 08052049500197 - FEMINESS: 2021-11-10
• 08052049500012 - SUPERBIUM: 2021-08-24
• 08052049500005 - THERMI 250: 2020-11-30