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510(k) K240658

1060nm laser body slimming machine by Hebei JT Medical Co., Ltd. — Product Code PKT

K240658 is an FDA 510(k) premarket notification submitted by Hebei JT Medical Co., Ltd. for the device "1060nm laser body slimming machine". The FDA issued a decision of Substantially Equivalent on May 13, 2024. The device falls under product code PKT (Laser For Disruption Of Adipocyte Cells For Aesthetic Use), a Class II device regulated under 21 CFR 878.5400. Hebei JT Medical Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2024
Date Received
March 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Device Class
Class II
Regulation Number
878.5400
Review Panel
SU
Submission Type

Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.

Other clearances by Hebei JT Medical Co., Ltd.

  • K250722 — Nd: YAG Laser Therapy System (QN-1) (June 6, 2025)
  • K232181 — Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) (April 24, 2024)

Other clearances for product code PKT

  • K233962 — ReBorn (1050nm) (April 16, 2024)
  • K231971 — DEKA PHYSIQ 360 (September 26, 2023)
  • K231131 — Diode Laser Body Sculpture Systems (June 22, 2023)
  • K222226 — EON (February 17, 2023)
  • K222265 — Diosculpt (September 23, 2022)
  • K211681 — EON (March 30, 2022)
  • K212331 — BodySculp (November 9, 2021)
  • K211402 — Powersculp laser lipolysis system (July 30, 2021)
  • K192970 — SLIMUS (December 1, 2020)
  • K201731 — Diode Laser Body Sculpture System (September 10, 2020)

FDA data resources