# K101555: CO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Technology Laser Co., Ltd.
- Decided: Sep 17, 2010 after 105 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). 16 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063001: Slim Evolution Family of CO2 Lasers and Delivery Device Accessories, Lasering S.R.L. (2007) Summary page 2.

## Most influential descendants
- K110434: Trixel CO2 Laser (2011), 15 descendants of its own
- K161925: CO2 Laser Therapy Machine (2016), 14 descendants of its own
- K192528: CO2 Laser Therapy System (2019), 8 descendants of its own
- K200042: CO2 Laser System (2020), 5 descendants of its own
- K162398: CO2 Laser Therapy Systems (2017), 2 descendants of its own

## Indications for use
eBeam CO 2 Laser System 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), general surgery, gynecology, podiatry, dental and otorhinolaryngology Dermatology, Plastic Surgery and General Surgery procedures including but not limited to: Laser skin resurfacing Treatment of fin-rows and wrinkles Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation. Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications. Blepharoplasty Site preparation for hair transplants Dental procedure including but not limited to - Periodontal procedures such as - gingivectomy, removal of hyperplasias gingivoplasty (incision and excision); Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign /malignant lesion ablation, operculectomy and homeostasis Podiatry procedures including but not limited to - Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares. Otorhinolaryngology (ENT) procedures including but not limited to - Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucae vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps. Gynecology Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia. This device is for prescription use only. The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device.

Source page: https://510kreport.com/device/K101555
Methodology: https://510kreport.com/methodology