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510(k) Data Aggregation
K Number
K192620Device Name
SNA-001 Silver Photoparticle Topical Gel
Manufacturer
Date Cleared
2020-08-12
(324 days)
Product Code
Regulation Number
878.4810Why did this record match?
Product Code :
QCY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SNA-001 Silver Photoparticle Topical Gel is indicated for use as an accessory to 810 mm diode laser for temporary removal of light-colored hair in patients with skin types I, II and III. Light-colored hair types include blonde, light red, light brown, gray and white.
Device Description
SNA-001 Silver Photoparticle Topical Gel (SNA-001) is used as an accessory to 810 nm diode dermatologic lasers for the removal of unwanted body hair. SNA-001 consists of near-infrared lightabsorbing silver particles suspended in a topical gel that mediates selective photothermolysis of the hair follicle when illuminated by a specific wavelength of laser light (810 nm). The photoparticles are nanoscale silver plates coated with silica and tuned to a wavelength of 810 nm corresponding to commonly used dermatologic lasers. These photoparticles function as highly efficient chromophores for the absorption of laser light. When exposed to laser light of the appropriate wavelength, the photoparticles rapidly heat to temperatures capable of facilitating targeted damage to the hair follicle . SNA-001 is dark blue/black in color, is for single use only, and is provided non-sterile in 1cc polypropylene syringe dispensers.
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K Number
K181518Device Name
Sebacia Microparticles
Manufacturer
Date Cleared
2018-09-06
(90 days)
Regulation Number
878.4810Why did this record match?
Product Code :
QCY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sebacia Microparticles are indicated for use as an accessory to 1064 nm lasers to facilitate photothermal heating of sebaceous glands for the treatment of mild to moderate inflammatory acne vulgaris.
Device Description
Sebacia Microparticles are a non-sterile, single-use product that is topically applied to the face for the purpose of supporting and supplementing the performance of legally marketed 1064 nm medical lasers for dermatologic use. The liquid suspension contains microparticles comprised of a silica core wrapped in a gold shell and coated with polyethylene glycol. The Sebacia Microparticles are topically applied to the face followed by gentle agitation of the skin surface using a mechanical massager and irradiated with a commercially available 1064 nm laser that heats the microparticles resulting in localized selective photothermolysis.
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