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510(k) K231971

DEKA PHYSIQ 360 by El.En S.P.A. — Product Code PKT

K231971 is an FDA 510(k) premarket notification submitted by El.En S.P.A. for the device "DEKA PHYSIQ 360". The FDA issued a decision of Substantially Equivalent on September 26, 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. El.En S.P.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2023
Date Received
July 3, 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 El.En S.P.A.

  • K260647 — SPECCHIO (April 2, 2026)
  • K251432 — Olo (August 6, 2025)
  • K243683 — Deka Bluebeam (June 12, 2025)
  • K250281 — DEKA LOTUS (February 26, 2025)
  • K241459 — MOTUS PRO Family (June 21, 2024)
  • K233473 — DEKA LOTUS (May 16, 2024)
  • K240752 — DEKA TORO (May 16, 2024)
  • K234057 — NIRVANA (April 10, 2024)
  • K240537 — SMARTXIDE PRO (March 20, 2024)
  • K240497 — Smartxide Tetra Pro (March 12, 2024)

Other clearances for product code PKT

  • K240658 — 1060nm laser body slimming machine (May 13, 2024)
  • K233962 — ReBorn (1050nm) (April 16, 2024)
  • 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)
  • K201731 — Diode Laser Body Sculpture System (September 10, 2020)

FDA data resources