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510(k) K201731

Diode Laser Body Sculpture System by Shanghai Apolo Medical Technology Co., Ltd. — Product Code PKT

K201731 is an FDA 510(k) premarket notification submitted by Shanghai Apolo Medical Technology Co., Ltd. for the device "Diode Laser Body Sculpture System". The FDA issued a decision of Substantially Equivalent on September 10, 2020. 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. Shanghai Apolo Medical Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2020
Date Received
June 24, 2020
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 Shanghai Apolo Medical Technology Co., Ltd.

  • K260256 — Q-Switched Nd: YAG Laser Systems (May 4, 2026)
  • K260017 — Picosecond Nd:YAG Laser Systems (Model: HS-298) (April 9, 2026)
  • K251031 — Fiber Laser Treatment Systems (HS-232,HS-233) (July 2, 2025)
  • K232409 — Electromagnetic Stimulation Systems (April 10, 2024)
  • K221770 — Fiber Laser Treatment System (October 13, 2022)
  • K203395 — Platform treatment system (January 28, 2022)
  • K201109 — CO2 Laser Therapy System (July 15, 2020)
  • K200116 — PicoSecond Nd: YAG Laser System (May 28, 2020)
  • K200746 — IPL Treatment Systems (May 15, 2020)
  • K200118 — Diode Laser Therapy Device (April 17, 2020)

Other clearances for product code PKT

  • K240658 — 1060nm laser body slimming machine (May 13, 2024)
  • 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)

FDA data resources