# K063001: Slim Evolution Family of CO2 Lasers and Delivery Device Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Lasering S.R.L.
- Decided: Mar 7, 2007 after 156 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: 3 generations back to K936109 (1994). 15 ancestors in all.
63 later devices descend from it; 7 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963339: Coherent Ultrapulse CO2 Surgical Lasers, Coherent Medical Group (1997) Summary page 1.
- K963229: Sharplan Models 20C, 30C, and 40C CO2 Lasers, Sharplan Lasers, Inc. (1996) Summary page 1.
- K933918: Sharplan Model 1080S CO2 Surgical Laser, Sharplan Lasers, Inc. (1994) Summary page 1.
- K900076: Sharplan Flexible CO2 Surgical Laser Applicator, Sharplan Lasers, Inc. (1990) Summary page 1.
- K950725: Sharplan Model 1015 CO2 Laser, Sharplan Lasers, Inc. (1995) Summary page 1.
- K955621: Sharplan Lasers, Inc Silktouch 2 Flash Scanner, Sharplan Lasers, Inc. (1996) Summary page 1.
- K960521: Sharplan Lasers, Inc. Silktouch Flash Scanner, Sharplan Lasers, Inc. (1996) Summary page 1.
- K881953: Sharplan Models 719/719SR/719SL Colposlad Cos SU, Sharplan Lasers, Inc. (1988) Summary page 1.
- K951204: Sharplan Model 712 Acuspot Micromanipulator, Sharplan Lasers, Inc. (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K062032: Accusoft, Accusoft XL, Direx Systems Corp. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K091115: ECO2 Laser System (2009), 27 descendants of its own
- K123573: Youlaser CO2 Laser (2013), 19 descendants of its own
- K101555: CO2 Laser System (2010), 16 descendants of its own
- K110434: Trixel CO2 Laser (2011), 15 descendants of its own
- K080463: Alma Lasers Thermoxel CO2 Laser System and Delivery Device Accessories (2008), 15 descendants of its own

## Indications for use
The SLIM Evolution Family of C02 Lasers 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 including but not limited to - 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 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, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps. Gynecology Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia. Laparoscopic treatment endometrial lesions, ablation of endometriosis, fimbroplasty, Tubal microsurgery, salpingostomy, histerectomy, uterine myomas and fibroids

Source page: https://510kreport.com/device/K063001
Methodology: https://510kreport.com/methodology