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510(k) K252786

Led Light Phototherapy Bed (Pro 450/ GY-680A) by Shenzhen Suyzeko Limited. — Product Code OLI

K252786 is an FDA 510(k) premarket notification submitted by Shenzhen Suyzeko Limited. for the device "Led Light Phototherapy Bed (Pro 450/ GY-680A)". The FDA issued a decision of Substantially Equivalent on December 1, 2025. The device falls under product code OLI (Fat Reducing Low Level Laser), a Class II device regulated under 21 CFR 878.5400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2025
Date Received
September 2, 2025
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 for product code OLI

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  • 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)
  • 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)
  • K202955 — Contour Light CL-100 (May 19, 2021)

FDA data resources