Fraxel FTX MCSYSFTX

GUDID 00816995027805

FRAXEL FTX CONSOLE, NEXT GENERATION

SOLTA MEDICAL

Dermatological laser beam guiding handpiece

• Primary Device ID: 00816995027805
• NIH Device Record Key: 5894a948-09f2-4916-b6b8-14acbe3e70f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fraxel FTX
• Version Model Number: MCSYSFTX
• Catalog Number: MCSYSFTX
• Company DUNS: 079999584
• Company Name: SOLTA MEDICAL
• 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	00816995027805 [Primary]

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: 2025-04-10
• Device Publish Date: 2025-04-02

On-Brand Devices [Fraxel FTX]

• 00816995027805: FRAXEL FTX CONSOLE, NEXT GENERATION
• 00816995027799: REFURBISHED FRAXEL FTX CONSOLE, NEXT GENERATION
• 00816995027782: TIP 7MM, FRAXEL NG, 12-PACK
• 00816995027775: TIP 15MM, FRAXEL NG, 12-PACK + AUTHENTICATOR