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510(k) K202955

Contour Light CL-100 by Contour Research, LLC — Product Code OLI

K202955 is an FDA 510(k) premarket notification submitted by Contour Research, LLC for the device "Contour Light CL-100". The FDA issued a decision of Substantially Equivalent on May 19, 2021. The device falls under product code OLI (Fat Reducing Low Level Laser), a Class II device regulated under 21 CFR 878.5400. Contour Research, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2021
Date Received
September 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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 Contour Research, LLC

  • K243854 — Contour Light (CL-100) (February 13, 2026)

Other clearances for product code OLI

  • K260688 — Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) (May 4, 2026)
  • K260129 — Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) (April 15, 2026)
  • 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)
  • K243811 — Erchonia Zerona® VZ8 (January 10, 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)

FDA data resources