Search Results
Found 3 results
510(k) Data Aggregation
K Number
K091796Device Name
SOFTLASE PRO, ORTHOLASE AND HYGIENELASE
Manufacturer
ZAP LASERS, LLC
Date Cleared
2009-07-31
(44 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ZAP LASERS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SoftLase Pro™/OrthoLase™/HygieneLase™ is to provide the ability to perform intraoral soft tissue maxilla-facial dental. general, oral and i cosmetic surgery. The SoftLase ProTM/OrthoLase™/HygieneLase™ is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system.
The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharneeal indications for use for which the device will be marketed:
-Excision and Incision Biopsies
-Hemostatic assistance
-Treatment of Apthous Ulcers
-Frenectomy
-Frenotomy
-Gingival Incision and Excision
-Gingivectomy
-Gingivoplasty
-Incising and Draining of Abscesses
-Operculectomy
-Oral Papillectomy
-Removal of Fibromas
-Soft Tissue Crown Lengthening
-Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
-Tissue retraction for Impression
-Vestibuloplasty
-Light activation of bleaching materials for teeth whitening
-Laser-assisted bleaching/whitening of teeth
Device Description
Not Found
Ask a Question
K Number
K081214Device Name
STYLA MICROLASER AND STYLAORTHO
Manufacturer
ZAP LASERS, LLC
Date Cleared
2008-05-14
(14 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ZAP LASERS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Styla MicroLaser™/StylaOrtho™ is to provide the ability to perform intraoral soft tissue dental, general, oral maxilla-facial and cosmetic surgery. The Styla MicroLaser™/StylaOrtho™ is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system.
The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharingeal indications for use for which the device will be marketed:
-Excision and Incision Biopsies
-Hemostatic assistance
-Treatment of Apthous Ulcers
-Frenectomy
-Frenotomy
-Gingival Incision and Excision
-Gingivectomy
-Gingivoplasty
-Incising and Draining of Abscesses
-Operculectomy
-Oral Papillectomy
-Removal of Fibromas
-Soft Tissue Crown Lengthening
-Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
-Tissue retraction for Impression
-Vestibuloplasty
-Light activation of bleaching materials for teeth whitening
-Laser-assisted bleaching/whitening of teeth
Device Description
The Styla MicroLaser™/StylaOrtho™ are the first soft-tissue laser developed as a handheld unit. It is wireless, lightweight, easy to set up, simple to use, requires less power, and cost efficient.
With the Styla MicroLaser™/StylaOrtho™ Zap Lasers introduces a miniature X-Y adjusting module for coupling a diode laser with a disposable fiber. Fiber accuracy is better than 5 um and the alignment is extremely stable. A module with a specific lens was developed by Zap Lasers in order to achieve such precision and alignment. Such a design greatly simplifies the fiber management and setup of operatory time as the fiber is attached into the tip allowing this item to be disposable and simple to be used. No fiber scoring is needed as the disposable tip is provided already scored to decrease setup tip and user's error.
The Laser and Control Box comprise the following major modules:
The laser diode assembly contains one single emitter laser diode of 2.0 watt output power (Class IV laser) lasing at 808 nm. The diode laser is directly coupled to a lens and aligned to the fiber optic inside the removable tips, using (patent pending) a 2 axis laser alignment system. It also contains a 5 m W power, 650 nm laser diode coupled to the same fiber optic. The laser's visible light is designed to aid the user to aim the tip of the delivery fiber onto the tissue.
The Styla Microlaser™/StylaOrtho™ is designed to dissipate heat during normal operation and may feel warm to the touch after prolonged use. The laser module is mounted towards the tip of the unit, which acts as a heat sink during normal operation. The temperature is monitored by a sensor that prevents overheating.
Laser power controller provides electric power to the diodes in continuous wave and pulsed mode. It supplies about 2 VDC and current up to 4A to the diodes. The controller contains a high efficiency DC to DC converter that converts the battery voltage to the precise voltage needed for laser operation. This ensures that the majority of the energy is used for light and not converted into heat.
The delivery tips with fiber built in consist of 400 micron core multi-mode optical fiber, and a precise alignment mechanism. The fiber is factory installed into the tip and requires no installation by the end user.
The foot-switch is a standard (UL-approved) commercial foot-switch that provides hands-free ON/OFF capabilities. This switch controls initiation/termination of laser power from the distal end of the delivery fiber wirelessly.
Ask a Question
K Number
K021227Device Name
SOFTLASE G2-SURGICAL DIODE LASER SYSTEM
Manufacturer
ZAP LASERS, LLC
Date Cleared
2002-06-26
(69 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ZAP LASERS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SoftLase G2 - Surgical Diode Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The SoftLase G2 is intended for ablating, incising, excising, vaporization and coagulation intraoral soft tissues using a contact fiber optic delivery system. The system is also intended for use in teeth whitening procedures.
The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following are the indications for use for which the device will be marketed:
-Excision and Incision Biopsies
-Hemostatic assistance
-Treatment of Apthous Ulcers
-Frenectomy
-Frenotomy
-Gingival Incision and Excision
-Gingivectomy
-Gingivoplasty
-Incising and Draining of Abscesses
-Operculectomy
-Oral Papillectomy
-Removal of Fibromas
-Exposure of interrupted teeth
-Soft Tissue Crown Lengthening
-Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
-Tissue retraction for Impression
-Vestibuloplasty
-Light activation of bleaching materials for teeth whitening
-Laser-assisted bleaching / whitening of teeth
Device Description
The laser diode assembly with fiber bundle, which contains 3 single diode lasers, each of 1.6 watt output power (Class IV lasers) lasing at about 808 nm. Each diode laser is coupled directly into a 200 um core optical fiber using a special positioner. The assembly also contains a 5-mw power - 650 nm pilot laser diode, which is coupled into the three core fibers. In the second version of the device, a single 5 Watt laser diode is used. A special optical system is implemented to focus its laser diode radiation into a delivery fiber. It allows an effective use of 300 um and 200 um fibers. In both versions, a visible light of pilot laser is used for aiming the tip of the delivering fiber onto the tissue.
The laser diode power supply, with two controller PCBs supplies power to the diodes in DC or pulsed mode.
The delivery fiber cables, consist of multi-mode, single core optical fibers available in 200, 300, 400 and 600 um diameters. The standard SMA 905 fiber connector terminates one end of the delivery fiber, which is attached to the SMA union at the rear panel of the laser box. The other end of the fiber is stripped of its protective jacket and is cleaved to provide laser radiation output.
The foot-switch, is a standard (UL-approved) commercial foot-switch/pedal that provides handsfree ON/OFF capabilities. This controls initiation/termination of laser power from the distal end of the delivery fiber. Each SoftLase G2 laser system is provided with two safety goggles, one fiber stripper and one sapphire wedge scribe for fiber cleaving.
Ask a Question
Page 1 of 1