# K974896: Laserscope EL Laser System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Mar 27, 1998 after 86 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.
519 later devices descend from it; 2 cite it directly.
0 of 520 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) Laserscope Erbium:YAG Laser System and Accessories: named in the summary without a submission number
- (no number) Continuum Biomedical CB Erbium/2.94™ Erbium:YAG Laser: named in the summary without a submission number
- (no number) Schwartz Electro-Optics, Inc. CLR 2940 Erbium Crystalase: named in the summary without a submission number
- (no number) Coherent UltraFine™ Erbium Laser: named in the summary without a submission number

## Most influential descendants
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own

## Indications for use
The Laserscope EL Laser System and Accessories are intended for the surgical incision/excision, vaporization, ablation 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: Indications include epidermal nevi, telangiectasia, spider veins, actinic chellitis, kelolds, 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: Indications include surgical incision/excision, vaporization, ablation 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 coagutation may be indicated. Genitourinary: Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (includes condyfoma acuminata, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon. Gynecology. Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma Oral/Maxillofacial: indications include benign oral tumors, oral and glossal lesions and gingivectomy. Otorhinolaryngology/Head and Neck (ENT): Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis; excision of carcinogenic tissue and oral leukoplakia. Ophthalmology: Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy. Podiatry: Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.

Source page: https://510kreport.com/device/K974896
Methodology: https://510kreport.com/methodology