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510(k) K211402

Powersculp laser lipolysis system by Lotuxs Medtech (Suzhou) Co., Ltd. — Product Code PKT

K211402 is an FDA 510(k) premarket notification submitted by Lotuxs Medtech (Suzhou) Co., Ltd. for the device "Powersculp laser lipolysis system". The FDA issued a decision of Substantially Equivalent on July 30, 2021. 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. Lotuxs Medtech (Suzhou) Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2021
Date Received
May 6, 2021
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 Lotuxs Medtech (Suzhou) Co., Ltd.

  • K222862 — SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC (July 30, 2023)

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)
  • K192970 — SLIMUS (December 1, 2020)
  • K201731 — Diode Laser Body Sculpture System (September 10, 2020)

FDA data resources