FDA 510(k) categories
Each category maps to an FDA three-letter product code. Open a category to browse clearances, companies, and technology filters.
GEX
Laser & light therapy
Powered laser and light-based surgical instruments for general surgery, dermatology, and plastic surgery (21 CFR 878.4810).
- Clearances
- 667
- Companies
- 262
Diode · Nd:YAG · CO2
OHT
OTC light-based hair removal
Over-the-counter light-based devices that use thermal energy for hair removal (21 CFR 878.4810, product code OHT).
- Clearances
- 145
- Companies
- 78
IPL · Diode laser · LED
GEI
Energy-based Device
Devices that utilize energy for therapeutic or surgical purposes, typically referenced under CFR 21 878.4810.
- Clearances
- 0
- Companies
- 0
OLO
Robotic Surgical Navigation System
Devices that assist in surgical navigation using robotic technology for improved precision and outcomes.
- Clearances
- 0
- Companies
- 0