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510(k) K080300

CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) by Cutera, Inc. — Product Code NUV

K080300 is an FDA 510(k) premarket notification submitted by Cutera, Inc. for the device "CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)". The FDA issued a decision of Substantially Equivalent on April 8, 2008. The device falls under product code NUV (Massager, Vacuum, Light Induced Heating), a Class II device regulated under 21 CFR 878.4810. Cutera, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2008
Date Received
February 5, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Vacuum, Light Induced Heating
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

The device is intended to temporarily alter the appearance of cellulite

Other clearances by Cutera, Inc.

  • K251149 — AviClear Laser System (July 11, 2025)
  • K233237 — xeo+ Family (December 15, 2023)
  • K230660 — AviClear Laser System (June 6, 2023)
  • K223110 — truSculpt iD (November 3, 2022)
  • K221407 — truSculpt iD (July 13, 2022)
  • K213461 — AviClear Laser System (March 24, 2022)
  • K182997 — enlighten III Laser System (December 12, 2018)
  • K180709 — truSculpt RF Device; truSculpt; truSculpt 3D (June 6, 2018)
  • K172077 — Cutera enlighten III Laser System (October 27, 2017)
  • K172004 — truSculpt (August 2, 2017)

Other clearances for product code NUV

  • K231092 — T-SHAPE 2 (September 22, 2023)
  • K211272 — ICOONE Laser Med (also referred to as ICOONE Medical laser) (June 22, 2021)
  • K182453 — ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) (January 11, 2019)
  • K161892 — Slimming Treatment Device (March 2, 2017)
  • K131362 — INMODE WMBODY DEVICE (October 8, 2013)
  • K122579 — VELASHAPE (September 13, 2012)
  • K101147 — MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM (January 21, 2011)
  • K101366 — I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) (September 17, 2010)
  • K100230 — SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V (April 2, 2010)
  • K092195 — CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) (October 1, 2009)

FDA data resources