# K110984: Slim E30 II CO2 Laser

- Pathway: 510(k) (Special)
- Applicant: Lasering S.R.L.
- Decided: Jul 22, 2011 after 106 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
No predicates in its family tree.
23 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K123573: Youlaser CO2 Laser (2013), 19 descendants of its own
- K160312: Fraxis Duo (2016), 14 descendants of its own
- K170325: Secret RF (2017), 10 descendants of its own
- K210084: Silkro (2022), 3 descendants of its own
- K180654: PINXEL-RF system (2018), 3 descendants of its own

## Indications for use
The SLIM Evolution 11 C02 Laser and delivery device accessories are intended for use in surgical applications that require 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. Laser skin resurfacing Treatment of furrows and wrinkles Removal of skin tags, actinic keratosis, acne scars, keloids, tattos, 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 MiXto fractional scanner only for treatment of wrinkles and skin resurfacing Dental procedure including. 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. Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixeetorny and verrucae vulgares. Otorhinolaryngology (ENT) procedures. Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomnatosis polyps. Gynecology Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia. Laparoscopic treatment endometrial lesions, ablation of endometriosis, fimnbroplasty, Tubal microsurgery, salpingostomy, histerectomy, uterine myomas and fibroids

Source page: https://510kreport.com/device/K110984
Methodology: https://510kreport.com/methodology