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K Number
K980398Device Name
KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II
Manufacturer
Date Cleared
1998-09-22
(232 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
OPTOMEDIC MEDICAL TECHNOLOGIES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Kaplan PenduLaser 115 Surgical Laser with OptoScan II Scanner accessory is indicated for surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: Dermatology, Plastic Surgery, Podiatry, Neurosurgery, Gynecology, Otorhinolaryngology, Arthroscopy (knee), Open & Endoscopic General Surgery.
The Kaplan PenduLaser 115 Surgical Laser with OptoScan II Scanner accessory is safe and effective when indicated for use in specific surgical applications including:
- Ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of laser skin resurfacing, laser derm-abrasion, and laser burn debridement.
- Laser skin resurfacing (ablation and/or vaporization) in dermatology and plastic surgery for the treatment of wrinkles, rhytids, and furrows.
- Laser skin resurfacing (ablation and/or vaporization) of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, solar/actinic elastosis, actinic cheilitis, lentinges, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous cell carcinoma, epidermal nevi, xanthelasma palpebrarum, syringoma, and verrucae vulgares (warts).
- Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery for the performance of blepharoplasty.
Device Description
The Kaplan PenduLaser 115 CO, Surgical Laser with OptoScan II Scanner Accessory consists of the laser, the Scanner Controller Box, a Footswitch Adapter box, the Sahar SofTouch Scanner, and the handpiece. The Controller houses the electronics and power supply and interfaces to the Pendulaser for communication through the Footswitch Adaptor Box.
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