FDA Product Codes for IPL Machines: ONE vs ONF vs OHT

All three entries can be confirmed in the classification database; clearance records are searchable in the 510(k) database.

FDA reviews over-the-counter home-use devices to a different risk profile than professional instruments — different safety controls, different labeling, different indications. That is why home hair removal devices carry OHT, not ONE/ONF. The procurement implication is simple: a K number for a home-use IPL is not evidence for a professional machine, and vice versa. When you verify a supplier’s claim (see our verification walkthrough), check that the product code matches the class of equipment on the quotation.

The functional difference is in the name: ONF covers powered light based instruments where a thermal effect is part of the intended use. In procurement terms, read the indications for use in the clearance letter rather than debating code semantics — the indications state what the device was actually reviewed to do, and that is what must match your intended treatments.

• Get the K number for the exact model.
• Open it in the 510(k) database: decision = SE, product code = ONE or ONF for professional equipment (OHT would be a red flag on a professional quotation).
• Read the indications for use — hair removal? skin rejuvenation? acne? — and match them to your treatment menu.
• Confirm the applicant is the manufacturer you are buying from.

For lasers rather than IPL, see our GEX explainer page; for every code at a glance, see the product code cheat sheet.

Last updated: October 11, 2026. Product codes and regulatory references were verified against official FDA sources (openFDA / accessdata.fda.gov) on this date. This page provides general purchasing information, not legal advice; regulations change, so confirm requirements at the time you buy.

Working with multiple suppliers and want a second pair of eyes on specifications and market availability? contact the LEIJEX team or review our manufacturing and quality system.