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510(k) K152280

BioPhotas Celluma3 by Biophotas, Inc. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2016
Date Received
August 12, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type

Other clearances by Biophotas, Inc.

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

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