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510(k) K243811

Erchonia Zerona® VZ8 by Erchonia Corporation — Product Code OLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2025
Date Received
December 11, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Fat Reducing Low Level Laser
Device Class
Class II
Regulation Number
878.5400
Review Panel
SU
Submission Type

Non-invasive reduction in fat layer for body contouring

Other clearances by Erchonia Corporation

  • K251903 — Erchonia DPN Laser (Model# EVRL) (February 19, 2026)
  • K252574 — Erchonia CLX (Model # CFL) (December 15, 2025)
  • K251843 — Erchonia EVRL (September 12, 2025)
  • K231409 — Erchonia FX-405 (August 11, 2023)
  • K231474 — Erchonia Violet ZERONA® Z6 OTC (July 21, 2023)
  • K221987 — Erchonia GVL (September 1, 2022)
  • K220519 — Erchonia Zerona Z-Bed (March 24, 2022)
  • K212595 — Erchonia FX-405 (November 12, 2021)
  • K211186 — Erchonia XLR8 (October 22, 2021)
  • K192544 — Erchonia Emerald (January 13, 2020)

Other clearances for product code OLI

  • K243854 — Contour Light (CL-100) (February 13, 2026)
  • K252574 — Erchonia CLX (Model # CFL) (December 15, 2025)
  • K252786 — Led Light Phototherapy Bed (Pro 450/ GY-680A) (December 1, 2025)
  • K232977 — Biophotas Celluma CONTOUR (November 21, 2023)
  • K231474 — Erchonia Violet ZERONA® Z6 OTC (July 21, 2023)
  • K220519 — Erchonia Zerona Z-Bed (March 24, 2022)
  • K213534 — PHantom Trilogy (March 11, 2022)
  • K202955 — Contour Light CL-100 (May 19, 2021)
  • K202361 — UltraSlim Digital, UltraSmooth Digital (December 18, 2020)
  • K192275 — invisa-RED ELITE (August 19, 2020)