# K024204: Fotona Fidelis Plus ND:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Jul 7, 2003 after 199 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
No predicates in its family tree.
200 later devices descend from it; 2 cite it directly.
0 of 201 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 its predicate without a number.
- (no number) Sunlase 8001 Nd:YAG laser system: named in the summary without a submission number

## Most influential descendants
- K070355: Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family (2008), 194 descendants of its own
- K083889: Fotona QX ND:Yag/KTP Laser System Family (2009), 166 descendants of its own
- K103455: Spectra Laser System (2011), 92 descendants of its own
- K093162: Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis, Powerlase at / Fidelis ER Iii D, HT Fid (2010), 83 descendants of its own
- K113588: Spectra Laser System (2012), 82 descendants of its own

## Indications for use
The Fotona Fidelis Plus Nd:YAG Laser System and Accessories is intended for inusion. excision and coagulation of intraoral soft tissue, including the marginal and interdental gingiva. This includes incising, excising and coagulating the epithelium lining. the free or marginal gingiva, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket). Excisionat and incisional biopsies Excision and vaporization of herpex simplex I and I1 Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Laser assisted uvulopaletoplasty (LAUP) Leukoplakia Operculectomy Oral papillectomies Pulpotomy and pulpotomy as an adjunct to root canal therapy Reduction of denture hyperplasia Reduction of gingival hypertrophy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy Removal of post-surgical granulations Soft tissue crown lengthening Sulculardebridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility) Tissue retraction for impression Treatment of apthous ulcers Vestibuloptasty

Source page: https://510kreport.com/device/K024204
Methodology: https://510kreport.com/methodology