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510(k) K180631

Silk Voice by Sofregen Medical, Inc. — Product Code MIX

K180631 is an FDA 510(k) premarket notification submitted by Sofregen Medical, Inc. for the device "Silk Voice". The FDA issued a decision of Substantially Equivalent on November 8, 2018. The device falls under product code MIX (System, Vocal Cord Medialization), a Class II device regulated under 21 CFR 874.3620. Sofregen Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2018
Date Received
March 9, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Vocal Cord Medialization
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Other clearances by Sofregen Medical, Inc.

  • K240919 — Silk Voice (SMI-04) (May 3, 2024)
  • K172545 — SERI Contour (September 22, 2017)

Other clearances for product code MIX

  • K240919 — Silk Voice (SMI-04) (May 3, 2024)
  • K150400 — Renu Gel (April 6, 2015)
  • K121795 — CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT (February 22, 2013)
  • K083783 — VF LIQUIGEL (September 11, 2009)
  • K081815 — VOCALIS GEL (January 5, 2009)
  • K081816 — VOCALIS AND VOCALIS SM (January 5, 2009)
  • K080956 — MODIFICATION TO VF GEL PLUS (April 25, 2008)
  • K071663 — VF GEL PLUS (February 15, 2008)
  • K070090 — RADIESSE LARYNGEAL IMPLANT (March 1, 2007)
  • K060815 — JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT (April 18, 2006)

FDA data resources