PRO Pen Microneedling System 6883

GUDID 00666151621305

The PRO Pen Microneedling System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older.

Dermalogica, LLC

Cosmetic micro-needling electronic handpiece, professional

• Primary Device ID: 00666151621305
• NIH Device Record Key: 1e946556-7b74-4570-aa33-091b21cb8037
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRO Pen Microneedling System
• Version Model Number: 6883
• Catalog Number: 6883
• Company DUNS: 177698560
• Company Name: Dermalogica, LLC
• 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: 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

Customer Support Contacts

• Phone: +1 (800) 345-2761
• Email: customer.service@dermalogica.com
• Phone: +1 (800) 345-2761
• Email: customer.service@dermalogica.com
• Phone: +1 (800) 345-2761
• Email: customer.service@dermalogica.com
• Phone: +1 (800) 345-2761
• Email: customer.service@dermalogica.com
• Phone: +1 (800) 345-2761
• Email: customer.service@dermalogica.com
• Phone: +1 (800) 345-2761
• Email: customer.service@dermalogica.com
• Phone: +1 (800) 345-2761
• Email: customer.service@dermalogica.com
• Phone: +1 (800) 345-2761
• Email: customer.service@dermalogica.com
• Phone: +1 (800) 345-2761
• Email: customer.service@dermalogica.com
• Phone: +1 (800) 345-2761
• Email: customer.service@dermalogica.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00666151621305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243800

FDA Product Code

• QAI: Powered Microneedle Device

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: 2026-02-09
• Device Publish Date: 2026-01-31

Devices Manufactured by Dermalogica, LLC

• 00666151621244 - PRO Pen 14-Pin Microneedling Cartridge: 2026-02-09 PRO Pen 14-Pin Microneedling Cartridges. The PRO Pen Microneedling System is a microneedling device and accessories intended to
• 00666151621305 - PRO Pen Microneedling System: 2026-02-09The PRO Pen Microneedling System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older.
• 00666151621305 - PRO Pen Microneedling System: 2026-02-09 The PRO Pen Microneedling System is a microneedling device and accessories intended to be used as a treatment to improve the app