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510(k) K233962

ReBorn (1050nm) by Lightfective , Ltd. — Product Code PKT

K233962 is an FDA 510(k) premarket notification submitted by Lightfective , Ltd. for the device "ReBorn (1050nm)". The FDA issued a decision of Substantially Equivalent on April 16, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2024
Date Received
December 15, 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 for product code PKT

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  • 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