510(k) · Cleared
ClearedWallach Quantum 500 Electrosurgical Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallach Surgical Devices, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 22, 1999 after a 161-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 22, 1999
- Review
- 161 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
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- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
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…
Read the full statement (121 words)
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983208: Wallach Quantum 500 Electrosurgical Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983208
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026