Silk Voice (SMI-04)— 510(k) K240919

Substantially Equivalent

Sofregen Medical

FDA 510(k) clearance K240919 for Silk Voice (SMI-04), Substantially Equivalent on 2024-05-03. Applicant: Sofregen Medical. Device class: 2.

Clearance details

Applicant: Sofregen Medical
Product code: Code MIX
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2024-04-03
Decision date: 2024-05-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Framingham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MIX

K180631 — Silk Voice2018-11-08
K150400 — Renu Gel2015-04-06
K121795 — CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT2013-02-22
K083783 — VF LIQUIGEL2009-09-11
K081815 — VOCALIS GEL2009-01-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.