# K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Oct 30, 2002 after 127 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: 4 generations back to K936109 (1994). 24 ancestors in all.
376 later devices descend from it; 21 cite it directly.
0 of 401 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974789: Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L, Lumenis, Inc. (1998) Summary page 1.
- K935563: Sharplan Surgical CO2 Lasers and Accessories, Sharplan Lasers, Inc. (1994) Summary page 1.
- K963229: Sharplan Models 20C, 30C, and 40C CO2 Lasers, Sharplan Lasers, Inc. (1996) Summary page 1.
- K933918: Sharplan Model 1080S CO2 Surgical Laser, Sharplan Lasers, Inc. (1994) Summary page 1.
- K991628: Modified LX-20 CO2 Laser System Family, LX-20SA, Esc Medical Systems, Inc. (1999) Summary page 1.
- K983215: Multipulse CO2 Laser, Aesculap-Meditec GmbH (1998) Summary page 1.
- K991297: Uni-Laser 450P CO2 Laser System & Accessories, Medart Corp. (1999) Summary page 1.
- K900076: Sharplan Flexible CO2 Surgical Laser Applicator, Sharplan Lasers, Inc. (1990) Summary page 1.
- K950725: Sharplan Model 1015 CO2 Laser, Sharplan Lasers, Inc. (1995) Summary page 1.
- K955621: Sharplan Lasers, Inc Silktouch 2 Flash Scanner, Sharplan Lasers, Inc. (1996) Summary page 1.
- K960521: Sharplan Lasers, Inc. Silktouch Flash Scanner, Sharplan Lasers, Inc. (1996) Summary page 1.
- K963339: Coherent Ultrapulse CO2 Surgical Lasers, Coherent Medical Group (1997) Summary page 1.
- K951204: Sharplan Model 712 Acuspot Micromanipulator, Sharplan Lasers, Inc. (1995) Summary page 1.
- K822136: Laser Bronchoscope, Laser Industries of Tel Aviv (1982) Summary page 1.
- K943700: Karl Storz Bronchoscope Accessories, KARL STORZ Endoscopy-America, Inc. (1994) Summary page 1.
- K881953: Sharplan Models 719/719SR/719SL Colposlad Cos SU, Sharplan Lasers, Inc. (1988) Summary page 1.
- K951812: Modified Coherent Ultrapulse CO2 Surgical Lasers, Lumenis, Inc. (1995) Summary page 1.

## Most influential descendants
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers (2003), 323 descendants of its own
- K031795: Reliant Laser System (2003), 318 descendants of its own
- K040617: Reliant Laser System II (2004), 316 descendants of its own
- K042319: Reliant Laser II System and Accessories (2005), 284 descendants of its own
- K060301: Palomar LUX1540 Handpiece (2006), 260 descendants of its own

## Indications for use
The Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers are indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: laser skin resurfacing; laser derm-abrasion; laser burn debridement. Laser skin resurfacing (ablation &/or vaporization) for treatment of: wrinkles, rhytids, and furrows Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, &/or treatment of: keratoses, including actinic keratosis; solar/actinic elastosis; cheilitis, including actinic cheilitis; lentigines; uneven pigmentation/ dyschromia; acne scars; surgical scars; keloids; hemangiomas (including Buccal and port wine); tattoos; telangiectasia; removal of small skin tumors; superficial pigmented lesions; adenosebaceous hypertrophy; rhinophyma reduction; cutaneous papilloma (skin tags); milia; debridement of eczematous or infected skin; basal and squamous cell carcinoma; nevi, including spider and epidermal; neurofibromas; tricoepitheliomas; xanthelasma palpebrarum; syringoma Laser ablation, vaporization and/or excision for complete and partial nail matrixectomy Vaporization/coagulation of: benign/malignant vascular/avascular skin lesions; Moh's Surgery; lipectomy; verrucae and seborrhoecae vulgares; Laser incision &/or excision of soft tissue for the performance of blepharoplasty. Laser incision &/or excision of soft tissue for the creation of recipient sites for hair transplantation Podiatry Laser ablation, vaporization &/or excision of soft tissue for the reduction, removal, &/or treatment of: verrucae vulgares/plantar (warts); fungal nail treatment; porokeratoma ablation; ingrown nail treatment; neuromas/fibromas, including Morton's neuroma; debridement of ulcers; other soft tissue lesions. Laser ablation, vaporization and/or excision in podiatry for complete and partial matrixectomy; Otolaryngology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for treatment of: choanal atresia; leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue; nasal obstruction; adult and juvenile papillomatosis polyps; polypectomy of nose and nasal passages; lymphangioma removal; removal of vocal cord nodules and polyps; removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords; laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue; stenosis, including subglottic stenosis; tonsillectomy (including tonsilar cryptolysis and neoplasma); pulmonary bronchial and tracheal lesion removal; benign and malignant nodules and tumors (larynx, pharynx, trachea); benign and malignant lesions (nose and nasal passages); benign and malignant tumors (oral); stapedotomy/stapedectomy; acoustic neuroma in ear; superficial lesions of the ear; telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue); cordectomy and cordal lesions of larynx, pharynx and trachea; myringotomy/tympanostomy; uvulopalatoplasty (LAUP, laser UPPP), turbinectomy; partial glossectomy; tumor resection on oral, subfacial and neck tissues; rhinophyma; verrucae vulgares (warts); gingivoplasty/gingivectomy Gynecology Laser incision, ablation and/or vaporization of soft tissue in GYN for treatment of: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); condyloma acuminata, including cervical, genital, vulvar and perineal; leukoplakia (vulvar dystrophies); incision and drainage of Bartholin’s and nabothian cysts; herpes vaporization; urethral caruncle vaporization; cervical dysplasia; benign and malignant tumors; hemangiomas GYN Laparoscopy Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery including GYN laparoscopy for treatment of: endometrial lesions, including ablation of endometriosis; excision/lysis of adhesions; salpingostomy; fimbroplasty; metroplasty; microsurgery (tubal); uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectomy Neurosurgery Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of: Cranial posterior fossa tumors; peripheral neurectomy; benign and malignant tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas and large tumors); arteriovenous malformation; pituitary gland tumors (transphenoidal approach) Spinal Cord incision/excision and vaporization of benign and malignant tumors and cysts; intra- and extradural lesions; laminectomy/ laminotomy/ microdiscectomy Orthopedics Incision/excision and vaporization of soft tissue in orthopedic surgery. Applications include: Arthroscopy meniscectomy; chondromalacia; chondroplasty; ligament release (lateral and other); excision of plica; partial synovectomy; General debridement of traumatic wounds; debridement of decubitus and diabetic ulcers; microsurgery; artificial joint revision; PMMA removal; General/Thoracic Surgery Incision/excision and vaporization of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include: debridement of decubitus ulcers, stasis, diabetic and other ulcers; mastectomy; debridement of burns; rectal and anal hemorrhoidectomy; breast biopsy; reduction mammoplasty; cytoreduction for metastatic disease; laparotomy and laparoscopic applications; mediastinal and thoracic lesions and abnormalities; skin tag vaporization; atheroma; cysts; pilonidal cyst removal and repair; abscesses; other soft tissue applications Dental/Oral Surgery Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: gingivectomy- removal of hyperplasias; gingivoplasty; incisional and excisional biopsy; treatment of ulcerous lesions, including aphthous ulcers; incision of infection when used with antibiotic therapy; frenectomy (frenum release); excision and ablation of benign and malignant lesions; hemostasis; operculectomy; crown lengthening; removal of soft tissue, cysts and tumors; oral cavity tumors and hemangiomas; abscesses; extraction site hemostasis; salivary gland pathologies; preprosthetic gum preparation; leukoplakia; partial glossectomy; periodontal gum resection Genitourinary Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include: benign and malignant lesions of external genitalia; condyloma; phimosis; erythroplasia

Source page: https://510kreport.com/device/K022060
Methodology: https://510kreport.com/methodology