# K963339: Coherent Ultrapulse CO2 Surgical Lasers - Pathway: 510(k) (Traditional) - Applicant: Coherent Medical Group - Decided: Jan 22, 1997 after 149 days - Product code: GEX (Powered Laser Surgical Instrument) - Device class: 2 - Regulation: 21 CFR 878.4810 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K936109 (1994). 8 ancestors in all. 675 later devices descend from it; 9 cite it directly. 0 of 684 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K951812: Modified Coherent Ultrapulse CO2 Surgical Lasers, Lumenis, Inc. (1995) Summary page 1. - K912029: Ultrapulse (TM) Carbon Dioxide Surgical Laser, Coherent Medical Group (1991) Summary page 1. - K946304: Coherent Family of CO2 Surgical Laser Scanner Handpieces, Lumenis, Inc. (1995) Summary page 1. - K853620: Model XA-50 - CO2 Surgical Laser, Xanar, Inc. (1986) Summary page 1. - K960521: Sharplan Lasers, Inc. Silktouch Flash Scanner, Sharplan Lasers, Inc. (1996) Summary page 1. - K955621: Sharplan Lasers, Inc Silktouch 2 Flash Scanner, Sharplan Lasers, Inc. (1996) Summary page 1. ## Most influential descendants - K974789: Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L (1998), 653 descendants of its own - K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories (2002), 376 descendants of its own - K990947: Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND: Yag Surgical Lasers and Delivery (1999), 350 descendants of its own - K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices (2001), 342 descendants of its own - K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers (2003), 323 descendants of its own ## Indications for 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. Otorhinolaryngology (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. Source page: https://510kreport.com/device/K963339 Methodology: https://510kreport.com/methodology