GentleMax Pro Plus

FDA 510(k) Premarket Notification · Submission K201111 · Applicant: Candela Corporation

Public Record 510(k) Submission Decision Date: 2020-05-26 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K201111.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K201111
Applicant / Sponsor
Device Name
GentleMax Pro Plus
Product Code
GEX
Decision Date
2020-05-26
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
General, Plastic Surgery (SU)
Clearance Type
Special
Third Party Flag
N
Date Received
2020-04-27

Related Establishments / Registrations

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.

Account Required Full available specs will require a free AvaSpecs account.