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510(k) Data Aggregation
K Number
K152280Device Name
BioPhotas Celluma3
Manufacturer
BIOPHOTAS, INC
Date Cleared
2016-03-02
(203 days)
Product Code
ILY, OHS, OLP
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
BIOPHOTAS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioPhotas Celluma3 is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris. The Celluma3 is intended to emit energy in the red and infrared spectrum for use in dermatology for the treatment of periorbital wrinkles.
Device Description
The Celluma3 is a highly shapeable LED panel designed to fit the contours of the target areas of the anatomy, covered with biocompatible material, which uses specific wavelengths of light to manage aesthetic and musculoskeletal conditions. Celluma3 produces light in the near infrared region of the spectrum (880nm) intended to provide topical heating to tissue for pain relief. Blue light (464nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) in combination with infrared light is intended to improve the appearance of wrinkles. Note that the Cellumad and the Celluma predicate device are technologically identical; only the indications for use have been revised to add treatment of periorbital wrinkles.
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K Number
K131113Device Name
BIOPHOTAS CELLUMA
Manufacturer
BIOPHOTAS, INC.
Date Cleared
2014-01-15
(268 days)
Product Code
ILY, GEX
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
BIOPHOTAS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biophotas Celluma® device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum is intended to reduce mild to moderate inflammatory acne vulgaris.
Device Description
The BioPhotas Celluma® is a therapeutic device using wavelengths of polychromatic energy produced by super-luminous LEDs (light emitting diodes) to treat a variety of skin and body conditions. It is a pain-free means to address a variety of musculoskeletal concerns. The Celluma® spectrum is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promotion of relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue light spectrum is intended to reduce mild to moderate acne vulgaris. Use of the combination of blue, red and near infrared regions of the spectrum is intended to emit energy to treat various conditions, specifically indicated to treat mild to moderate inflammatory acne vulgaris.
The BioPhotas Celluma® is a portable, ACpowered, software operated device intended for use on areas of the body such as the back, face, knees or other areas where the therapeutic light may be beneficial. Drawing electrical energy through an AC power adaptor to a lightweight, flame-retardant plastic user interface console that connects by a cable to a flexible panel within which is mounted an array of LEDs which provide red light (640 nm) and near IR (880 nm) wavelengths necessary, the Celluma® provides topical heating to elevate tissue temperature for the temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain or muscle spasms and to provide a temporary increase in local blood circulation.
Blue LEDs, adjacent to the other LEDs, mounted within the flexible panel provide blue spectrum light (463 nm) intended to reduce mild to moderate inflammatory acne vulgaris.
The flexible panel is designed to conform to the contour of the treatment site providing for ease of use for sites that may be difficult to reach for larger, more cumbersome devices. The patient-facing surface of the panel may contact the tissue of the patient, and is therefore composed of biocompatible Poron material.
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K Number
K122237Device Name
BIOPHOTAS LIFELIGHT
Manufacturer
BIOPHOTAS, INC.
Date Cleared
2013-01-03
(161 days)
Product Code
ILY, GEX
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
BIOPHOTAS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biophotas LifeLight device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
The blue spectrum light is intended to reduce the appearance of mild to moderate acne vulgaris.
Device Description
The LifeLight® is a lightweight device which uses specific wavelengths of light, produced by light emitting diodes (LEDs), to manage aesthetic conditions. LifeLight produces light in the near infrared region of the spectrum (880 nm) intended to provide topical heating to tissue. Blue light (464 nm) is intended to help reduce the appearance of mild to moderate acne. The console of the device contains the electronics of the device and an automatic shut-off safety feature. The LifeLight operates for 30 minutes per use.
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