# K244060: eCO2 3D

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Jul 31, 2025 after 212 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: 15 generations back to K910422 (1992). 185 ancestors in all.
No later device cites it as a predicate yet.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100610: Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser Systems, Lutronic Corporation (2011) Summary page 6.

## Indications for use
The eCO2 3D Laser System with fractional 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 eCO2 3D Laser System using the non-fractional handpieces (F100, F50, Zoom, and 500 micron tip) is also indicated for use in skin resurfacing and surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, and podiatry. 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, 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. 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.

Source page: https://510kreport.com/device/K244060
Methodology: https://510kreport.com/methodology