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510(k) K081815

VOCALIS GEL by Cytophil, Inc. — Product Code MIX

K081815 is an FDA 510(k) premarket notification submitted by Cytophil, Inc. for the device "VOCALIS GEL". The FDA issued a decision of Substantially Equivalent on January 5, 2009. The device falls under product code MIX (System, Vocal Cord Medialization), a Class II device regulated under 21 CFR 874.3620. Cytophil, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2009
Date Received
June 26, 2008
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 Cytophil, Inc.

  • K150400 — Renu Gel (April 6, 2015)
  • K121795 — CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT (February 22, 2013)
  • K102937 — OSTEOPHIL BETA-TCP (December 27, 2010)
  • K093871 — PERIOPHIL B-TCP (April 22, 2010)
  • K092788 — PERIOPHIL BIPHASIC (December 18, 2009)
  • K081816 — VOCALIS AND VOCALIS SM (January 5, 2009)
  • K072219 — CYTOPHIL TISSUE MARKER (January 18, 2008)

Other clearances for product code MIX

  • K240919 — Silk Voice (SMI-04) (May 3, 2024)
  • K180631 — Silk Voice (November 8, 2018)
  • K150400 — Renu Gel (April 6, 2015)
  • K121795 — CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT (February 22, 2013)
  • K083783 — VF LIQUIGEL (September 11, 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