FDA-cleared AI general and plastic surgery devices
The FDA's AI-enabled device list has 9 devices whose lead review panel is General and Plastic Surgery, 0.6% of all 1,614 listed devices. They come from 9 companies. The first decision was on November 1, 2011 and the most recent on May 21, 2026.
9AI devices
8Companies
2011First decision
2026-05-21Latest decision
Trend: devices per year
201120122017202420252026
Top companies
Most common product codes
All 9 devices, newest first
- DeepView AI® Systemspectralmd, inc. · General and Plastic Surgery
- Claire OCT SystemPerimeter Medical Imaging Ai, Inc. · General and Plastic Surgery
- HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)Procept Biorobotics · General and Plastic Surgery
- Maestro System (REF100)Moon Surgical · General and Plastic Surgery
- HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept BioRobotics · General and Plastic Surgery
- DermaSensorDermaSensor Inc. · General and Plastic Surgery
- NEVISENSESCIBASE AB · General and Plastic Surgery
- DUNE MEDICAL DEVICES MARGINPROBE SYSTEMDilon Medical Technologies, Ltd. · General and Plastic Surgery
- MELAFINDSTRATA SKIN SCIENCES, INC. · General and Plastic Surgery
Frequently asked questions
How many FDA-cleared AI general and plastic surgery devices are there?
As of the FDA list updated through June 29, 2026, 9 AI-enabled devices have General and Plastic Surgery as their lead review panel (0.6% of the list).
Which companies have the most AI general and plastic surgery devices?
spectralmd, inc. (1), Perimeter Medical Imaging Ai, Inc. (1), Procept Biorobotics (1) have the most AI-enabled general and plastic surgery devices on the FDA list.
Which year had the most AI general and plastic surgery authorizations?
2024 had the most, with 2 devices.
Which FDA pathways are used for AI general and plastic surgery devices?
PMA: 4; 510(k): 3; De Novo: 2.
What was the most recent AI general and plastic surgery device on the list?
DeepView AI® System from spectralmd, inc. (DEN250028), with a decision dated May 21, 2026.