← FDA Medical Device Classifications
Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
QGM · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4405
Classification
- FDA Product Code
QGM- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 878.4405
- Review panel
- SU
- Medical specialty
- General, Plastic Surgery
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.
Market data
- Cleared 510(k) submissions
- 3
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown