FDA records show ordinary powered microneedling devices for aesthetic use are classified under product code QAI (21 CFR 878.4430), while the Define RF Microneedling System (510(k) K232301) is classified under the Electrosurgical, Cutting & Coagulation & Accessories category FDA Product Classification: QAI (Powered Microneedle Device) 510(k) Premarket Notification K232301: Define RF Microneedling System. This page reports that regulatory distinction; it does not write "FDA approved", endorse efficacy, generalize the specific RF record to all RF devices, or draw a Biomaser regulatory conclusion.
Key takeaways
- Ordinary powered microneedling devices for aesthetic use are classified under FDA product code QAI (21 CFR 878.4430).
- The Define RF Microneedling System (K232301) is classified under the Electrosurgical, Cutting & Coagulation & Accessories category.
- These are device-specific classification records; not all RF microneedling devices share the K232301 classification.
- This page does not state "FDA approved" (510(k) is clearance, not approval) and is not an efficacy endorsement.
- No Biomaser product regulatory conclusion is drawn.
What the FDA records show
The FDA product classification places ordinary powered microneedling devices for aesthetic use under product code QAI (21 CFR 878.4430, 510(k) pathway, General & Plastic Surgery panel) FDA Product Classification: QAI (Powered Microneedle Device). Separately, the Define RF Microneedling System (510(k) K232301) is classified under the Electrosurgical, Cutting & Coagulation & Accessories category 510(k) Premarket Notification K232301: Define RF Microneedling System. The records are device-specific.
Evidence limits
- These are classification records, not approvals or efficacy endorsements; 510(k) is clearance, not "FDA approved".
- The K232301 classification applies to that specific RF system; it is not generalized to all RF microneedling devices.
- No Biomaser product regulatory conclusion is made on this page.
- For the FDA component description and target-area classification, see the FDA component description and the FDA target-area classification.
Frequently asked questions
Is the Define RF Microneedling System "FDA approved"? This page does not state "FDA approved". The record is a 510(k) clearance (K232301) with a specific classification; 510(k) is not approval and this page is not an efficacy endorsement.
Does the K232301 classification apply to all RF microneedling devices? No. It applies to the specific Define RF Microneedling System record; this page does not generalize it to all RF devices.
Does this page say anything about Biomaser products? No Biomaser product regulatory conclusion is drawn here.
For education, not as medical advice: check with a qualified clinician and always follow the device's instructions-for-use.