Aesthetic Device Compliance Guides

A buyer-oriented knowledge base on how energy-based aesthetic devices (lasers, IPL, RF, ultrasound) are regulated in the United States, how to verify supplier claims in official FDA databases, and what the marks on a device actually mean. Written from a manufacturer’s field experience of what distributors and clinic owners ask most.

• FDA Registered, Cleared, or Approved? What Aesthetic Device Buyers Get Wrong
• How to Verify a Supplier’s FDA Claim in 10 Minutes
• FDA 510(k) Clearance for Aesthetic Lasers: Product Codes, Timeline, and Cost
• FDA Product Code GEX Explained
• FDA Product Codes for IPL Machines: ONE vs ONF vs OHT
• FDA Product Codes for Aesthetic Devices: Cheat Sheet (21 CFR 878.4810)
• Importing Laser Hair Removal Machines into the US: A Distributor’s FDA Checklist
• CE Marking vs FDA 510(k) vs NMPA: What Each Mark Actually Means

For treatment- and term-level definitions, see our aesthetic glossary. For general information on how our devices are built and tested, see intelligent manufacturing and quality control.