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510(k) Data Aggregation
K Number
K232977Device Name
Biophotas Celluma CONTOUR
Manufacturer
Biophotas Inc
Date Cleared
2023-11-21
(61 days)
Product Code
OLI, ILY, OHS
Regulation Number
878.5400Why did this record match?
Applicant Name (Manufacturer) :
Biophotas Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BIOPHOTAS Celluma CONTOUR is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
The BIOPHOTAS Celluma CONTOUR is intended to deliver heat in the near infra-red 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 BioPhotas Celluma CONTOUR is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.
Device Description
The BioPhotas Celluma CONTOUR is a Light emitting diode (LED) system that applies 640nm light for the purpose of reducing the circumference of the hips, waist, and thighs for aesthetic benefit, 640nm and 880nm light for the purpose of temporarily elevating skin temperature and 640nm and 880nm light for the purpose of treating full face wrinkles.
The BioPhotas Celluma CONTOUR comprises of a flexible, shape-taking frame upon which is mounted an array of LEDs, this allows the device to be contoured to the treatment area. The LEDs are embedded within a biocompatible foam covering that holds a transparent polycarbonate cover recessed within it. The biocompatibility nature of allows the device to be placed in contact with the skin.
The flexible LED panel is permanently connected by a three-foot long cable attached to a control panel that contains the circuitry and software that controls the device. The control panel contains several push buttons beneath a sealed cover. A power button that switches the device ON/OFF, a mode button that allows the user to select from 3 preprogrammed treatment modes "Contour" "wrinkles" and "Aches and Pains", and a Start button that activates the desired treatment mode. The control panel receives its power from a separate cable that connects via an AC adaptor for 110-220 Volts to a standard U.S. electrical power outlet. The control panel contains an automatic shut-off safety feature.
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K Number
K211038Device Name
Biophotas Celluma RESTORE
Manufacturer
Biophotas INC
Date Cleared
2021-06-29
(83 days)
Product Code
OAP
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 RESTORE system is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
Device Description
The BioPhotas Celluma RESTORE system uses visible red light (640nm) and is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
In addition, the Biophotas Celluma RESTORE is a portable, therapeutic device whose purpose is to provide even, cool, narrow-band wavelengths of polychromatic light (blue, 465nm red, 640nm and Near infra-red, 880nm) produced by super-luminous LEDs (light emitting diodes) to treat a variety of skin and musculoskeletal conditions as previously cleared under K122237, K131113, K152280 and K171323.
The system comprises of a flexible, shape-taking frame upon which is mounted an array of LEDs, this allows the device to be contoured to the treatment area. The LEDs are embedded within a biocompatible foam covering that holds a transparent polycarbonate cover recessed within it. The biocompatibility nature of allows the device to be placed in contact with the skin. Nevertheless, the design of the device provides for maintaining a small distance between the surface of the skin and the surface of the device.
The flexible LED panel is permanently connected by a three-foot long cable attached to a control panel that contains the circuitry and software that controls the device. The control panel contains several push buttons beneath a sealed cover. A power button that switches the device ON/OFF, a mode button that allows the user to select from 3 preprogrammed treatment modes "Hair", "Wrinkles", and "Aches and Pains", and a Start button that activates the desired treatment mode. The control panel receives its power from a separate cable that connects via an AC adaptor for 110-220 Volts to a standard U.S. electrical power outlet. The control panel contains an automatic shut-off safety feature.
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K Number
K171323Device Name
BIOPHOTAS CELLUMA3
Manufacturer
Biophotas Inc
Date Cleared
2017-09-01
(119 days)
Product Code
OHS
Regulation Number
878.4810Why 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 emit energy in the visible and infrared region of the spectrum for use in the treatment of full face wrinkles.
Device Description
The Biophotas Celluma is a portable, therapeutic device whose purpose is to provide even, cool, narrow-band wavelengths of polychromatic light (blue, 465nm red, 640nm and Near infrared, 880nm) produced by super-luminous LEDs (light emitting diodes) to treat a variety of skin and musculoskeletal conditions. The Celluma' uses a combination of visible red light (640mm) in combination with near infrared light (880nm) and is intended to improve the appearance of full-face wrinkles. Near infra-red (880nm) is intended to provide topical heating tissue temperature: for the temporary relief of minor muscles and joint pain, arthritis and muscle spasm; relieving stiffness; promotion the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum (465nm) is intended to reduce mild to moderate inflammatory acne vulgaris. The Biophotas Celluma' is intended for use on areas of the body such as the full face, back, chest, knees or other areas where the therapeutic light may be beneficial. The system comprises of a semi-rigid, shape-taking frame upon which is mounted an array of LEDs, this allows the device to be contoured to the treatment area. The LEDs are embedded within a biocompatible Poron® foam covering that holds a transparent polycarbonate cover recessed within it. The biocompatibility nature of Poron® allows the device to be placed in contact with the skin. Nevertheless, the design of the device provides for maintaining a small distance between the surface of the skin and the surface of the device. The flexible LED panel is permanently connected by a three-foot long cable attached to a control panel that contains the circuitry and software that controls the device. The control panel contains several push buttons beneath a sealed cover. A power button that switches the device ON/OFF, a mode button that allows the user to select from 3 preprogrammed treatment modes; "Acne", "Wrinkles", and "Aches and Pains", a pulse button which allows the user to switch between pulse (default setting) or non-Pulse and a Start button that activates the desired treatment mode. The control panel receives its power from a separate cable that connects via an AC adaptor for 110-220 Volts to a standard U.S. electrical power outlet. The control panel contains an automatic shut-off safety feature.
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