← FDA Medical Device Classifications
Powered Microneedle Device
QAI · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4430
Classification
- FDA Product Code
QAI- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 878.4430
- Review panel
- SU
- Medical specialty
- General, Plastic Surgery
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.
Market data
- Cleared 510(k) submissions
- 25
- Registered establishments
- 54
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown