# K013255: Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF

- Pathway: 510(k) (Traditional)
- Applicant: Ellman Intl., Inc.
- Decided: Nov 7, 2001 after 40 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
Longest line of descent: 1 generation back to K933157 (1994). 2 ancestors in all.
104 later devices descend from it; 6 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001253: Surgitron Iec II, Ellman Intl., Inc. (2000) Summary page 2.
- K933157: Erbotom Icc 200, Erbe USA, Inc. (1994) Summary page 2.

## Most influential descendants
- K082834: Ellman International Non-Ablative Technique for Surgitron  Iec (2009), 56 descendants of its own
- K101967: Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve' (2010), 53 descendants of its own
- K102368: Non-Ablative Wrinkle Treatment Handpiece (2010), 52 descendants of its own
- K102698: Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve Glidesafe (2011), 39 descendants of its own
- K061174: Surgi-Max (2006), 35 descendants of its own

## Indications for use
is idendical to the Surgitron as a preammendment device such as: * Cutting Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Blepharoplasty, * Blended Cutting and Coagulation Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Tags, Papilloma Keloids, Keratosis, Verrncae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, 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/K013255
Methodology: https://510kreport.com/methodology