Clearance Summary
PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE received FDA 510(k) clearance under submission number K092066, sponsored by Andrew Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2010-04-12.
- Submission: K092066
- Applicant / Sponsor: Andrew Technologies, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5040
- Decision date: 2010-04-12
Classification & Regulation
This clearance is catalogued under FDA product code QPB and 21 CFR 878.5040, within the General, Plastic Surgery review panel as a Class II device.