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510(k) K232977

Biophotas Celluma CONTOUR by Biophotas, Inc. — Product Code OLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2023
Date Received
September 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fat Reducing Low Level Laser
Device Class
Class II
Regulation Number
878.5400
Review Panel
SU
Submission Type

Non-invasive reduction in fat layer for body contouring

Other clearances by Biophotas, Inc.

  • K211038 — Biophotas Celluma RESTORE (June 29, 2021)
  • K171323 — BIOPHOTAS CELLUMA3 (September 1, 2017)
  • K152280 — BioPhotas Celluma3 (March 2, 2016)
  • K131113 — BIOPHOTAS CELLUMA (January 15, 2014)
  • K122237 — BIOPHOTAS LIFELIGHT (January 3, 2013)

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