# K123366: Surgitron 4.0 Dual RF S5-Iec

- Pathway: 510(k) (Traditional)
- Applicant: Ellman International, Inc.
- Decided: Jul 12, 2013 after 254 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K943450 (1995). 30 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013255: Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF, Ellman Intl., Inc. (2001)
- K082834: Ellman International Non-Ablative Technique for Surgitron  Iec, Ellman Int'L, Inc. (2009) Summary page 1.

## Most influential descendants
- K182365: TempSure System (2018), 15 descendants of its own
- K190678: TempSure (2019), 14 descendants of its own
- K200241: TempSure System (2020), 13 descendants of its own
- K211639: BTL-785W (2022), 7 descendants of its own
- K222556: BTL-785X (2023), 5 descendants of its own

## Recalls of this device
- Sep 7, 2016 · Class II · Z-0748-2017: Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not match. The expiration date on the box is correct with a date of 2018-02.

## Indications for use
The Surgitron 4.0 Dual RF S5 - IEC is indicated for: * Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes II-V * Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty. * Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, and development of skin flaps. * Hemostasis: control of bleeding, epilation, telangiectasia. * Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, hemostasis. * Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.

Source page: https://510kreport.com/device/K123366
Methodology: https://510kreport.com/methodology