# K082834: Ellman International Non-Ablative Technique for Surgitron  Iec

- Pathway: 510(k) (Traditional)
- Applicant: Ellman Int'L, Inc.
- Decided: May 7, 2009 after 223 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: 11 generations back to K943450 (1995). 29 ancestors in all.
56 later devices descend from it; 6 cite it directly.
0 of 86 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) Summary page 1.
- K040135: Thermage Thermacool System, Thermage, Inc. (2004) Summary page 3.

## Most influential descendants
- 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
- K132665: Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - Iec (2013), 17 descendants of its own
- K132431: Thermage CPT System (2013), 17 descendants of its own

## Recalls of this device
- May 4, 2012 · Not classified · Z-1624-2012: Ellman International is recalling its Pelleve reusable handpiece because of possible cable failure and sparking.

## Indications for use
Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV The device is also indicated for: 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, epithelidma, 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/K082834
Methodology: https://510kreport.com/methodology