# K991628: Modified LX-20 CO2 Laser System Family, LX-20SA

- Pathway: 510(k) (Traditional)
- Applicant: Esc Medical Systems, Inc.
- Decided: Aug 9, 1999 after 90 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: 2 generations back to K953074 (1995). 4 ancestors in all.
377 later devices descend from it; 2 cite it directly.
0 of 382 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960475: Modified Luxar LX-20 Family CO2 Laser System, Luxar Corp. (1996) Summary page 1.
- K963229: Sharplan Models 20C, 30C, and 40C CO2 Lasers, Sharplan Lasers, Inc. (1996) Summary page 1.
- K935563: Sharplan Surgical CO2 Lasers and Accessories, Sharplan Lasers, Inc. (1994) Summary page 1.

## Most influential descendants
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories (2002), 376 descendants of its own
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers (2003), 323 descendants of its own
- K031795: Reliant Laser System (2003), 318 descendants of its own
- K040617: Reliant Laser System II (2004), 316 descendants of its own
- K042319: Reliant Laser II System and Accessories (2005), 284 descendants of its own

## Indications for use
Representative examples: Tattoo removal; port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; keloid reduction; wart removal; basal & squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas, hemangiomas, nevi, and tricoepitheliomas; dermabrasion such as for lentigos, keratoses, actinic keratosis & cheilitis. Representative examples: Gingivectomy; frenum release; removal of soft tissue, cysts, and tumors. Representative examples: Menisectomy; chondromalacia ablation; partial synovectomy, lateral release; PMMA removal. Representative examples: Hemorrhoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of decubitus ulcers and statis ulcers; mastectomy, breast biopsy, reduction mammoplasty; cytoreduction for metastatic disease; many dermatological procedures. Representative examples: Subglottic stenosis vaporization; tonsillectomy; removal of vocal cord papillomas, nodules, and polyps; lymphangioma removal; pulmonary bronchial and tracheal lesion removal; turbinectomy; removal of leukoplakia of larynx; ablation of choanal atresia. Myringotomy/tympanostomy; Laser Assisted Uvulopalatoplasty (LAUP). Representative examples: Plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neruoma removal; ingrown nail treatment. Intended Use The modified LX-20 Laser System Family is a general surgical instrument used to vaporize, incise, excise, ablate, or photo coagulate soft tissue in surgical procedures in the listed surgical specialties. The system may be effectively utilized for those applications recognized as within the accepted indications for use of CO₂ laser devices performed within the listed specialties and which require power densities as calculated by power and spot size referenced in the power density charts in the operator's manual. Representative examples: Condyloma, excision and vaporization, cervical, vulvar, & perineal; vaginal intraepithelial neoplasia ablation (VAIN); vulvar intraepithelial neoplasia ablation (VIN); herpes vaporization; urethral caruncle vaporization; I&D Bartholin's & nubothian cysts. Vaporization, incision, excision, ablation, or photo coagulation of soft tissue in endoscopic and laparoscopic surgery including GYN laparoscopy where delivery of energy by the hollow fiber may be more convenient than delivery of energy by a handpiece. Representative examples: endometriosis ablation; excision of adhesions; salpingotomy; metroplasty.

Source page: https://510kreport.com/device/K991628
Methodology: https://510kreport.com/methodology