Part 878 Subpart F—Therapeutic Devices
FDA submissions for Part 878 Subpart F—Therapeutic Devices in the General, Plastic Surgery (SU) review panel, including product codes and regulations.
Section range: §§ 878.5070–878.5910
CFR Part: 878
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| FLJ | Unit, Airflow, Laminar | 878.5070 | 2 | 0 |
| FRT | Unit, Isolation, Surgical | 878.5070 | 2 | 0 |
| FYD | Apparatus, Exhaust, Surgical | 878.5070 | 2 | 75 |
| FZG | Apparatus, Air Handling, Bench | 878.5070 | 2 | 1 |
| FZH | Apparatus, Air Handling, Room | 878.5070 | 2 | 4 |
| FZI | Apparatus, Air Handling, Enclosure | 878.5070 | 2 | 5 |
| ORC | Air Filter Portable Apparatus | 878.5070 | 2 | 6 |
| QGI | Air-Handling Apparatus Accessory | 878.5080 | 1 | 0 |
| KCW | Epilator, High Frequency, Needle-Type | 878.5350 | 1 | 43 |
| KCX | Epilator, High Frequency, Tweezer-Type | 878.5360 | 1 | 25 |
| OLI | Fat Reducing Low Level Laser | 878.5400 | 2 | 32 |
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | 878.5400 | 2 | 19 |
| KPJ | Chamber, Oxygen, Topical, Extremity | 878.5650 | 2 | 23 |
| EYR | Tourniquet, Gastro-Urology | 878.5900 | 1 | 2 |
| GAX | Tourniquet, Nonpneumatic | 878.5900 | 1 | 20 |
| OJS | Tourniquet Kit | 878.5900 | 1 | 0 |
| KCY | Tourniquet, Pneumatic | 878.5910 | 1 | 34 |
| QGX | General Use Pneumatic Tourniquet | 878.5910 | 1 | 0 |
