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AQUABEAM System

by Procept Biorobotics, Corporation

De Novo DEN170024

AQUABEAM System is a medical device (FDA Class II; FDA product code PZP, Fluid Jet Removal System) made by Procept Biorobotics, Corporation, granted FDA De Novo DEN170024 on 21 Dec 2017, active as of 22 Oct 2026.

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA De Novo, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN170024 Date21 Dec 2017DecidedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA product code
PZP
Device class
Class II
Regulation
21 CFR Part 876.4350
Advisory committee
General, Plastic Surgery
FDA decision
DENG De Novo granted

Devices cleared under DEN170024

7 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under DEN170024
UDI-DISize and differences
AquaBeam Handpiece 310301
PROCEPT BioRobotics Corporation
310301B6143103011
Single use: yes
On the market
AquaBeam Handpiece HP2000
PROCEPT BioRobotics Corporation
HP2000 / HP2000B614HP20001
Single use: yes
On the market
AquaBeam Robotic System AB2000
PROCEPT BioRobotics Corporation
AB2000-D, AB2000-E / AB200000850055427020
Single use: no
On the market
AquaBeam Robotic System AB2000
PROCEPT BioRobotics Corporation
AB2000 / AB2000B614AB20001
Single use: no
On the market
AquaBeam Scope 210501
PROCEPT BioRobotics Corporation
210501 / 210501B6142105011
Single use: no
On the market
AquaBeam Scope SC2000
PROCEPT BioRobotics Corporation
SC2000-A / SC2000B614SC20001
Single use: no
On the market
AquaBeam System 210101
PROCEPT BioRobotics Corporation
210101 / 210101B6142101011
Single use: no
On the market

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