SUPERBIUM

GUDID 08052049500012

BIOS SRL

Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system

• Primary Device ID: 08052049500012
• NIH Device Record Key: 082f24c3-db86-44a8-a83f-0797df0ac976
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUPERBIUM
• Version Model Number: APMD116
• 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	08052049500012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153229

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: 4
• Public Version Date: 2021-08-24
• Device Publish Date: 2016-11-24

Devices Manufactured by BIOS SRL

• 08052049500289 - OptiPLUS: 2023-11-14
• 08052049500272 - OptiPLUS: 2023-08-31
• 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
• 08052049500012 - SUPERBIUM: 2021-08-24
• 08052049500005 - THERMI 250: 2020-11-30