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510(k) Data Aggregation
K Number
K000158Device Name
VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
Manufacturer
FISMA, INC.
Date Cleared
2000-08-24
(218 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FISMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991464Device Name
DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50
Manufacturer
FISMA, INC.
Date Cleared
1999-07-20
(84 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FISMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Laser-assisted Bleaching/Whitening of the teeth. Illumination purposes for the adjunctive use in caries detection and endodontic orifice location. Curing of all light sensitive bonding materials including: Pit and fissure sealants, composite restorations, endodontic composite cores, composite cements for porcelain facings and inlays, periodontal splint material, and prosthetic reline and repair material.
Device Description
The Dental 200, 300, & 400 Laser Systems are an instrument used in the application of Dentistry. With a level of output power of up to 10.0 Watts on some models, and the selectable blue or green wavelengths, additional indications for use are warranted. The use of these dental laser devices are supported by a line of FiberFlex™ Fibers in sizes of; 200, 300, 400, & 600 microns. Cannulas specifically designed for use in Dentistry and as companion to the bare fibers. The primary energy output source is an Argon Ion laser head for delivery to the patient. The selectable laser wavelength colors of green (treat) and blue (cure). This system has similar timing features for interval, and duration. The Aiming Beam is a visible Red Diode @ 630-680nm.
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K Number
K990174Device Name
ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV
Manufacturer
FISMA, INC.
Date Cleared
1999-04-01
(72 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FISMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
See attachment "B" for a complete listing of indicated uses (applied for).
Ophthalmology: (Atlas-Elite, Elite Ultra)
- Retinal Photocoagulation
- Trabeculoplasty
- Iridotomy
- Diabetic Retinopathy
- Peripheral Iridectomy
- Posterior and Anterior procedures
Ear, Nose, & Throat (ENT): (Atlas-Elite, Elite Ultra)
- Stapedectomy
- Stapedotomy
- Myringotomies
- Lysis of Adhesions
- Control of Bleeding
- Removal of Acoustic Neuromas
- Soft Tissue Adhesion in Micro/Macro Otologic procedures
- (Elite Ultra [4.0 Watt] only)
- Epistaxis (HHT)
- Partial Turbinate Reduction
- Vaporization/Coagulation of Granulation Tissue
- Photocoagulation or Vaporization of Soft or Fibrous Tissue
Dermatology: (Atlas-Elite, Elite Ultra, Corium 200, & Corium 400)
- Pigmented Lesions, inc. solar lentigines
- Vascular Lesions, inc. cherry hemangiomas & angiokeratomas
- Extremities Telangiectasias, inc. facial & leg telangiectasias
- Cutaneous Lesions
- Flat Warts
- Dermatosis
- Papulosa Nigra
Dentistry (Corium 200, Corium 400)
- Frenectomy
- Treatment of Oral Mucous Cysts
- Treatment of Benign Vascular Lesions:
- Capillary Hemangioma
- Hemorrhagic Hereditary Telangiectasia
- Capillary/Cavernous Hemangiomas
- Lymphongioma
- AV Malformation of the Tongue
- Hemanqiolymphangiomas
- Photocoagulation of Superficial Vessels
- Vaporization of Superficial Blood Vessels or Lymphs Containing Vessels
- Treatment of Superficial Tonque Lesions
- Tissue Management and Hemostasis for Crown and Bridge Impressions
- Incision and Drainage for Abscess
- Gingivoplasty/Gingivectomy:
- Operative Procedures
- Crown and Bridge, Gingival Retraction
- Crown Lengthening
- Hyperplasia (Drug, Irritation, Epulis, ... )
- Hemostasis during Dental Procedures
- Operculectorny (Operculotomy)
- Excisional Biopsy
- Free Gingival Graft (Adjunct):
- Hemostasis of Donor Site
- Hemostasis of Graft Site
- Vestibuloplasty
- Soften Gutta Percha
- Treatment of Canker Sores, Herpetic Lesions, and Aphthous Ulcers
- Laser-assisted bleaching/whitening
Device Description
The Diode Frequency Doubled Green Nd:YAG Surgical Laser System is an instrument used in the application of Photothermolysis (Photocoagulation) of soft tissue using a 532 nm wavelength. The laser light is produced by diode technology. With a higher level of output power of up to 10.0 Watts on future models, additional indications for use are warranted. Indications for use are supported by a line of collimated handpieces with spot sizes of: 200, 400, 600, 800, and 1200 microns, as well as, Slit Lamps (M-140 & M-150), Slit Lamp Attachments, (M-100 & M-101), Indirect Ophthalmoscopes, and Microfilters (Fixed and Moving).
The Elite Family's primary energy output source is a Diode Pumped Nd: YAG Rod, Frequency Doubled using a KTP crystal to a visible green 532 nm laser light for the delivery to the patient and treatment. This system has various timing features for interval, and duration. The Aiming Beam is a Visible Red Diode @ 620-640 nm wavelength.
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K Number
K963124Device Name
PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)
Manufacturer
FISMA, INC.
Date Cleared
1996-11-08
(88 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FISMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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