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510(k) Data Aggregation
K Number
K103118Device Name
REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR
Manufacturer
HOYA PHOTONICS, INC.
Date Cleared
2010-11-19
(29 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
HOYA PHOTONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Use: Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology. Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
Specific Indications:
- 1064 nm wavelength
- Tattoo Removal (dark ink: blue and black)
- Dermal Pigmented Lesions
- Nevus of Ota
- Removal or lightening of hair with or without adjuvant preparation.
- Skin Resurfacing for Acne Scars and Wrinkles
- Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)
532 nm wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional Multilite Dye Laser Handpiece)
- Tattoo removal (light ink: red, sky blue, green)
- Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
- Epidermal Pigmented lesions including but not limited to: cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus
- Skin Resurfacing for Acne Scars and Wrinkles
- Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)
Device Description
The RevLite Q-Switched Nd:YAG Laser System with Handpiece Adaptor consists of a electrically powered Console in which laser energy produced within the system is delivered to the tissue by means of an articulated arm, Handpiece Adaptor and specially designed Handpieces. The user activates laser emission by means of a footswitch.
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K Number
K050696Device Name
MEDLITE C1 Q-SWITCHED ND:YAG LASER
Manufacturer
HOYA PHOTONICS, INC.
Date Cleared
2005-06-17
(91 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
HOYA PHOTONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
Device Description
Not Found
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K Number
K050274Device Name
DIODENT II DENTAL LASER SYSTEM
Manufacturer
HOYA PHOTONICS, INC.
Date Cleared
2005-04-29
(81 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
HOYA PHOTONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.
Examples:
Excisional and incisional biopsies
Exposure of unerupted teeth
Fibroma removal
Frenectomy and frenotomy
Gingival troughing for crown impressions
Gingivectomy
Gingivoplasty
Gingival incision and excision
Hemostasis
Implant recovery
Incision and drainage of abscess
Leukoplakia
Operculectomy
Oral papillectomies
Pulpotomy
Pulpotomy as an adjunct to root canal therapy
Reduction of gingival hypertrophy
Soft tissue crown lengthening
Sucular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
Treatment of aphthous ulcers
Vestibuloplasty
Biopsy incision and excision
Lesion (tumor) removal
For light activation for bleaching materials for teeth whitening For laser-assisted bleaching/whitening for teeth.
Device Description
Not Found
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K Number
K041721Device Name
LVI AESTHETIC LASER
Manufacturer
HOYA PHOTONICS, INC.
Date Cleared
2004-08-05
(42 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
HOYA PHOTONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.
Examples:
Excisional and incisional biopsies
Exposure of unerupted teeth
Fibroma removal
Frenectomy and frenotomy
Gingival troughing for crown impressions
Gingivectomy
Gingivoplasty
Gingival incision and excision
Hemostasis
Implant recovery
Incision and drainage of abscess
Leukoplakia
Operculectomy
Oral papillectomies
Pulpotomy
Pulpotomy as an adjunct to root canal therapy
Reduction of gingival hypertrophy
Soft tissue crown lengthening
Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
Treatment of aphthous ulcers
Vestibuloplasty
Biopsy incision and excision
Lesion (tumor) removal
For light activation for bleaching materials for teeth whitening
For laser-assisted bleaching/whitening for teeth.
Device Description
Dental diode laser
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K Number
K032797Device Name
DELIGHT DENTAL ER: YAG LASER SYSTEM
Manufacturer
HOYA PHOTONICS, INC.
Date Cleared
2004-04-05
(210 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
HOYA PHOTONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cutting, shaving, contouring and resection of oral osseous tissues (bone).
Device Description
Not Found
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