PRO Pen Microneedling System (6883)
K-Number: K243800 · 2025-08-25
ApplicantDermalogica, LLC
Decision Date2025-08-25
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PRO Pen Microneedling System (6883) is a medical device manufactured by Dermalogica, LLC. It received FDA 510(k) clearance on 2025-08-25 under approval number K243800. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PRO Pen Microneedling System (6883)?
PRO Pen Microneedling System (6883) is a medical device that received FDA 510(k) clearance on 2025-08-25. It is manufactured by Dermalogica, LLC. The 510(k) number is K243800.
When was PRO Pen Microneedling System (6883) approved by the FDA?
PRO Pen Microneedling System (6883) received FDA 510(k) clearance on 2025-08-25, under approval number K243800.
What company makes PRO Pen Microneedling System (6883)?
PRO Pen Microneedling System (6883) is manufactured by Dermalogica, LLC.
What is the FDA product code for PRO Pen Microneedling System (6883)?
The FDA product code for PRO Pen Microneedling System (6883) is QAI.
Related Devices (Code: QAI)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.