Regulatory Actions

The FDA cleared eight microneedling devices under product code QAI between March 6, 2025 and May 13, 2026, the most recent decision on record. Every one is a prescription device. None was cleared for over-the-counter or home use, and four of the eight are cleared for one indication only: improving the appearance of facial acne…

Since January 6, 2026, two Dr. Pen handpieces, the A20 and A9, have held an active Health Canada medical device license (number 114618). That is a reversal for part of a brand that Health Canada told Canadians on December 16, 2021 not to buy or use, because “Dr. pen microneedling pens and cartridges are not…