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K Number
K963339Device Name
COHERENT ULTRAPULSE CO2 SURGICAL LASERS
Manufacturer
COHERENT MEDICAL GROUP
Date Cleared
1997-01-22
(149 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
COHERENT MEDICAL GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and the Delivery Accessories that are used with them to deliver light energy are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); arthroscopy (knee surgery); and open and endoscopic general surgery.
The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers are safe and effective when indicated for use in specific surgical applications including:
Dermatology & Plastic Surgery
- Ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery (using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces) in the performance of laser skin resurfacing and laser derm-abrasion (using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces), and laser burn debridement.
- Laser skin resurfacing (ablation and/or vaporization) in dermatology and plastic surgery using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces 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).
Dermatology, Plastic Surgery and General Surgery
- Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery for the performance of blepharoplasty.
- Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery for the creation of recipient sites for hair transplantation.
Podiatry
- Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares (warts)
- Laser ablation, vaporization, and/or excision in podiatry for matrixectomy.
Otorhinolarıngology (ENT)
- Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, adult and juvenile papillomatosis polyps, rhinophyma, and verrucae vulgares (warts).
Gynecology
- Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies), and vulvar and vaginal intraepithelial neoplasia
Neurosurgery
- Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.
Device Description
The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (and its delivery accessories) are intended to be used to deliver carbon dioxide light energy for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in a variety of medical specialties.
Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers are comprised of the following main components:
- a laser console and tower;
- a counterbalanced articulated arm and delivery system;
- control and display panels;
- footswitch and handswitch delivery controls;
- a remote control unit;
- a filtered air pump purge system; and
- a variety of delivery device accessories (handpieces, scanners, waveguides, micromanipulators, optical couplers and laparoscopic adapters, and insufflation and purge gas systems).
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K Number
K960032Device Name
COHERENT VERSAPULSE AESTHETIC SURGICAL LASERS
Manufacturer
COHERENT MEDICAL GROUP
Date Cleared
1996-04-01
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
COHERENT MEDICAL GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Coherent VersaPulse Aesthetic Surgical Lasers and the Delivery Accessories that are used with them to deliver 532 nm, 1064 nm and 755 nm laser energy that are indicated for use in surgical applications requiring photothermolysis of soft tissue, and 2940 nm laser energy that is indicted for use in surgical applications requiring excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.
Device Description
The Coherent VersaPulse Aesthetic Surgical Lasers (and its delivery accessories) are intended to be used to deliver: frequency doubled, Q-switched frequency doubled, and Q-switched Nd:YAG; Q-switched Alexandrite:YAG laser energy for use in surgical applications requiring the photothermolysis (photocoagulation) of soft tissue; and Er: Y AG laser energy for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.
Coherent VersaPulse Aesthetic Surgical Lasers are comprised of the following main components:
- · a laser console and tower;
- · a counterbalanced articulated arm and delivery systems;
- · a fiber port and delivery systems;
- · control and display panels;
- · footswitch and handswitch delivery controls;
- · a remote control unit; and
- · a variety of delivery device accessories (articulated arm and fiber handpieces, scanners, and epidermal cooling devices).
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