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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Celluma CLEAR; Celluma DELUX; Celluma DELUX XL; Celluma ELITE; Celluma FACE; Celluma HOME; Celluma iLITE; Celluma iPRO; Celluma LITE; Celluma MYSTIQUE; Celluma POD; Celluma PRO; Celluma PRO C3; Celluma RESTORE; Celluma Series 2 CONTOUR; Celluma Series 2 CONTOUR PLUS; Celluma Series 2 DELUX; Celluma Series 2 DELUX XL; Celluma Series 2 ELITE; Celluma Series 2 FACE; Celluma Series 2 LITE; Celluma Series 2 NOVA; Celluma Series 2 POD; Celluma Series 2 PRO; Celluma Series 2 PRO PLUS; Celluma Series 2 SKIN; Celluma SKIN; Celluma SPORT
Classification Name: LAMP, INFRARED, THERAPEUTIC HEATING
Product Code: ILY
Device Class: 2
Regulation Number: 890.5500
Medical Specialty: Physical Medicine
Registered Establishment Name: BIOPHOTAS, INC.
Registered Establishment Number: 3009765778
Premarket Submission Number: K152280
Owner/Operator: BioPhotas
Owner/Operator Number: 10041655
Establishment Operations: Manufacturer; Complaint File Establishment
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