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510(k) K231131

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

K231131 is an FDA 510(k) premarket notification submitted by Shanghai Bele Medical Technology Co.,Ltd for the device "Diode Laser Body Sculpture Systems". The FDA issued a decision of Substantially Equivalent on June 22, 2023. 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 Bele Medical Technology Co.,Ltd has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2023
Date Received
April 21, 2023
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 Bele Medical Technology Co.,Ltd

  • K240474 — Multi-function Platform Systems (BL-M10) (May 20, 2024)
  • K240386 — Picosecond Nd:YAG Laser Systems (BL-C10) (May 16, 2024)

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)
  • 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