# K990243: Fotona Fidelis ER:Yag Laser System & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Jun 9, 1999 after 135 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: 1 generation back to K971843 (1997). 2 ancestors in all.
64 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974896: Laserscope EL Laser System and Accessories, Laserscope (1998) Summary page 1.
- K971843: Laserscope Vela Erbium:Yag Laser System and Accessories, Laserscope (1997) Summary page 1.

## Most influential descendants
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own
- K153671: Family of CoolGlide Aesthetic Lasers (2016), 32 descendants of its own
- K170626: Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece (2017), 24 descendants of its own
- K172193: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules (2018), 22 descendants of its own
- K182088: XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro (2018), 20 descendants of its own

## Indications for use
The Fotona Fidelis Er:YAG Laser System and Accessories are intended for surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands Dermatology/Plastic Surgery : epidermal nevi, telangiectasia, spider veins, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacing, superficial skin lesions, and performing diagnostic biopsies. General Surgery : surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated Genitourinary : lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon Gynecology : cerivecal intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma Oral Surgery : benign oral tumors, oral and glossal lesions and gingivectomy, gingivoplasty, frenectomy, sulcular debridement - removal of diseased or inflamed soft tissue in the periodontal pocket — Cem Otorhinolaryngology/Head and Neck (ENT) : ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue and oral leukoplakia Ophthalmology : soft tissue surrounding the eye and orbit anterior capsulotomy Podiatry : warts, plantar verrucae, large mosaic verrucae and matrixectomy

Source page: https://510kreport.com/device/K990243
Methodology: https://510kreport.com/methodology