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510(k) Data Aggregation
K Number
K111689Device Name
STLASE
Manufacturer
DENTAL PHOTONICS, INC
Date Cleared
2012-02-16
(245 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DENTAL PHOTONICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The stLase with surgical laser operation (Automatic Power Control) that can be used in contact or non-contact technique, is indicated for dental soft tissue indications including: incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
The stLase with surgical laser operation that can be used in contact or non-contact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coagulation of soft tissue, and
The stLase with dental laser operation is intended to be used in contact or non-contact technique for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy, and light activation of bleaching materials for teeth whitening.
Device Description
The Dental Photonics stLase is a soft tissue surgical laser system indicated for use in dental applications. It can generate up to 25 W at 980 nm wavelength in fiberoptic output used for a variety of dental and oral surgical applications, including cutting and coagulation of intraoral and extraoral soft tissues.
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K Number
K094049Device Name
STLASE DIODE LASER
Manufacturer
DENTAL PHOTONICS, INC
Date Cleared
2010-09-10
(253 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DENTAL PHOTONICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The stLase™ with surgical laser operation that can be used in contact or noncontact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coagulation of soft tissue, and The stLase™ with dental laser operation that can be used in contact or non-contact technique is intended for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy, and light activation of bleaching materials for teeth whitening.
Device Description
The Dental Photonics stLase™ is a 980 nm wavelength diode laser intended for use in general surgical applications and dental laser applications.
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