QUADESSY Set Package

GUDID 08800016905045

CLASSYS Inc.

Intradermal radio-frequency ablation system

• Primary Device ID: 08800016905045
• NIH Device Record Key: 8bf9ab64-f5ce-4e19-b1bb-f026e7307d24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUADESSY Set Package
• Version Model Number: QD1-M400
• Company DUNS: 689842183
• Company Name: CLASSYS Inc.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	08800016905045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241157

FDA Product Code

• OUH: Skin Resurfacing Rf Applicator

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: 2025-07-10
• Device Publish Date: 2025-07-02

Devices Manufactured by CLASSYS Inc.

• 08800016903140 - Max-25: 2025-07-10
• 08800016903171 - Max-M25: 2025-07-10
• 08800016903423 - Max-25C: 2025-07-10
• 08800016903447 - Max-64C: 2025-07-10
• 08800016903454 - Max-M25C: 2025-07-10
• 08800016904246 - MTR-AC-01: 2025-07-10
• 08800016904253 - MTR-AC-04: 2025-07-10
• 08800016904291 - MTR-AC-27G: 2025-07-10