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510(k) K191068

Powersculp laser lipolysis system by Wuhan Lotuxs Technology Co., Ltd. — Product Code PKT

K191068 is an FDA 510(k) premarket notification submitted by Wuhan Lotuxs Technology Co., Ltd. for the device "Powersculp laser lipolysis system". The FDA issued a decision of Substantially Equivalent on July 17, 2019. 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. Wuhan Lotuxs Technology Co., Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2019
Date Received
April 22, 2019
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 Wuhan Lotuxs Technology Co., Ltd.

  • K231910 — DermRays Revive (January 30, 2024)
  • K232117 — Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) (November 28, 2023)
  • K230090 — Diode Laser Hair Removal (April 19, 2023)
  • K142845 — SILKPRO laser hair removal system (July 1, 2015)

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