# K083918: Atl CO2 Medical Laser Systems, Models Atl-150 and Atl-250

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Technology Laser Co., Ltd.
- Decided: Feb 2, 2009 after 34 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.
No later device cites it as a predicate yet.
0 of 17 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.

## Indications for use
The ATL Family of CO 2 Medical Laser Systems (and the delivery accessories that are used to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. Dermatology, Plastic Surgery and General Surgery procedures including but not limited to - > Treatment of furrows 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, LAUP and papillomatosis polyps. Gynecology > Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia.

Source page: https://510kreport.com/device/K083918
Methodology: https://510kreport.com/methodology