# K971843: Laserscope Vela Erbium:Yag Laser System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Jul 23, 1997 after 70 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.
573 later devices descend from it; 7 cite it directly.
0 of 574 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) Continuum Biomedical CB Erbium/2.94 Er:YAG Laser System: 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 VELA Erbium:YAG Laser System and Accessories are intended for the surgical incision/excision, vaporization and coagulation of soft tissue. All soft tissue is included, such as skin, 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 cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers and skin resurfacing. General Surgery: The Erbium:YAG laser is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application 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: Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (includes condyloma 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. ENT: Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis; excision of carcinogenic tissue, oral leukoplakia. Oral/Maxillofacial: Indications include benign oral tumors, oral and glossal lesions and gingivectomy. 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/K971843
Methodology: https://510kreport.com/methodology