# K983208: Wallach Quantum 500 Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Wallach Surgical Devices, Inc.
- Decided: Feb 22, 1999 after 161 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The intended use of the Quantum 500 Electrosurgical Generator is for all General & Plastic Surgery related in-office high frequency, electrosurglcal procedures. Some indications for applications include: 1) Cutting - skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, nevi, keratosis, oculoplastic procedures, blepharoplasty, aponeurotic repair, and levator resection. 2) Blended Cutting and Coagulation - skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, skin tags, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps, and oculoplastic procedures. 3) Hemostasis - control of bleeding, epilation, and telangiectasia. 4) Fulguration - basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, and hemostasis. 5) Bipolar - pmpomt precise coagulation. Pinpoint hemostasis in any field; wet or dry.

Source page: https://510kreport.com/device/K983208
Methodology: https://510kreport.com/methodology