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510(k) K070090

RADIESSE LARYNGEAL IMPLANT by Bioform Medical, Inc. — Product Code MIX

K070090 is an FDA 510(k) premarket notification submitted by Bioform Medical, Inc. for the device "RADIESSE LARYNGEAL IMPLANT". The FDA issued a decision of Substantially Equivalent on March 1, 2007. The device falls under product code MIX (System, Vocal Cord Medialization), a Class II device regulated under 21 CFR 874.3620. Bioform Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2007
Date Received
January 10, 2007
Clearance Type
Special
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 Bioform Medical, Inc.

  • K081729 — MODIFICATION TO GFX NERVE ABLATION SYSTEM (August 7, 2008)
  • K060815 — JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT (April 18, 2006)

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)
  • 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)
  • K060815 — JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT (April 18, 2006)

FDA data resources