# K100610: Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Jan 20, 2011 after 323 days
- Product code: ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output)
- 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: 14 generations back to K910422 (1992). 184 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091115: ECO2 Laser System, Lutronic Corporation (2009) Summary page 1.
- K091320: Spectra SP II, Spectra Denta II, Lutronic Corporation (2009) Summary page 1.

## Most influential descendants
- K111831: MX-7000 Microxel (2011), 1 descendant of its own
- K244060: eCO2 3D (2025), 0 descendants of its own
- K173359: Fractional CO2 Surgical Laser System (2018), 0 descendants of its own

## Indications for use
The eCO2 Plus Laser System with fractionated handpieces is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, flurrows, fine lines, textural irregularities, pigmented lesions and vascular dysebromia. The eCO2 Plus Laser System using the non-fractionated handpieces (Fl100, F50, and Zoom) is also 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), and open endoscopic general surgery. Dermnatolopv & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: * Laser skin resurfacing * Treatment of wrinkles, rhytids and furrows * Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dysebromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement. Dermnatology. Plastic Surgery & General Surgery Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications. Podiatry Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares, and matrixectomy. Otorhinolarynnology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, UPP, rhinophyma, adult and juvenile papillomatosis polyps, rhinophyma and verrucae vulgares. 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 neurology for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors. The DENTA III Laser System using the non-fractionated handpieces (Fl100, F50, and Zoom) is indicated for use in soft tissue dental indications including periodontic procedures such as, but not limited to, removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), vaporization, gingivectomny-removal of hyperplasias, gingivoplasty, papillectomy, vestibuloplasty, fibroma (nonmalignant tumor, mucosa, tongue), epulis, incision and excision, removal of soft tissue, cysts, and tumors, and laser assisted new attachment procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium); Oral surgery such as frenectomy, frenum release, drainage (abscess), flap surgery, incisional and excisional biopsy, incision and excision of apihous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, oral cavity tumors and hemangio~mas, salivary gland pathologies, preprosthetic gum preparation, leukoplakia; partial glossectomy, periodontal gum resection, homeostasis, operculectomy, and crown lengthening. The DENTA III+ Laser System using fractionated handpieces is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia. The DENTA HI1+ Laser System using non-fractionated handpieces (F 100, F50, and Zoom) is indicated for use in soft tissue dental indications including periodontic procedures such as, but not limited to, removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), vaporization, gingivectomny-removal of hyperplasias, gingivoplasty, papillectomy, vestibuloplasty, fibroma (nonmalignant tumor, mucosa, tongue), epulis, incision and excision, removal of soft tissue, cysts, and tumors, and laser assisted new attachment procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium); Oral surgery such as frenectomry, frenum release, drainage (abscess), flap surgery, incisional and excisional biopsy, incision and excision of aphthous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, oral cavity tumors and hemangiomas, salivary gland pathologies, preprosthetic gum preparation, leukoplakia; partial glossectomry, periodontal gum resection, homeostasis, operculectomy, and crown lengthening. The SP III Laser System using the non-fractionated handpieces (FlOC, F50, and Zoom) is 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), and open endoscopic general surgery. 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 * Treatment of wrinkles, rhytids and furrows * Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomras (including buccal hemangiomas), tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal naevi, xanthelasma. palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser bum debridement. Dermatology. Plastic Surgery & General Surgery Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications. Podiatry Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares, and matrixectomy. Otorhinolarvn2oloey (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, UPP, rhinophyma, adult and juvenile papillomnatosis polyps, rhinophyma and verrucae vulgares. Gvnecoloev Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acumninata, leukoplakia (vulvar dystrophies) and vulvar and vaginal intraepithelial neoplasia. Neurosureery Laser incision, excision, ablation and/or vaporization of soft tissue in neurology for the treatment of basal tumnor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.

Source page: https://510kreport.com/device/K100610
Methodology: https://510kreport.com/methodology