PRO Pen 14-Pin Microneedling Cartridge

Basic Information

• Brand Name: PRO Pen 14-Pin Microneedling Cartridge
• Primary DI: 00666151621244
• Version / Model: 6819
• Catalog Number: 6819
• Company Name: Dermalogica, LLC
• Labeler DUNS: 177698560
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-31
• Public Version: 1
• Public Version Date: 2026-02-09
• Public Version Status: New
• Public Device Record Key: 62e12b6f-36f5-4d7d-91fb-0a0485f643a5

Device Description

PRO Pen 14-Pin Microneedling Cartridges. 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QAI	Powered Microneedle Device	General, Plastic Surgery	878.4430	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61222	Cosmetic micro-needling electronic handpiece cartridge, professional	A device intended to be fitted to an electronic cosmetic micro-needling handpiece for the creation of high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It is a small, sealed cartridge containing micro-needles intended to be fitted to the distal tip of the handpiece; it does not include any injectable materials. It is intended to be used by a healthcare provider in a clinical setting. It is not intended to be used for energy-based skin treatment. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00666151621244	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K243800	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -18 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -18 – 60 Degrees Celsius