# K991632: Fotona Novalis ER: Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Aug 10, 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Laserscope Venus Erbium Laser System (EL Laser System): named in the summary without a submission number
- (no number) Continuum Biomedical (Con-Bio) CB Erbium/2.94 Er:YAG Laser: named in the summary without a submission number

## Indications for use
The Fotona Novalis 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/Maxillofacial : benign oral tumors, oral and glossal lesions and gingivectomy 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/K991632
Methodology: https://510kreport.com/methodology