# K992382: Surgitron Radiolase

- Pathway: 510(k) (Traditional)
- Applicant: Ellman Intl., Inc.
- Decided: Oct 14, 1999 after 90 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.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980177: Sugitron Model: Iec, Ellman Intl., Inc. (1998) Summary page 1.
- K933157: Erbotom Icc 200, Erbe USA, Inc. (1994) Summary page 1.

## Most influential descendants
- K014216: Secca System (2002), 5 descendants of its own
- K110143: Het Bipolar Electrocautery Forceps (2011), 3 descendants of its own
- K121085: Het Bipolar Ligator System (2012), 2 descendants of its own
- K140422: Het Systems, LLC, Het Bipolar Ligator System (2014), 1 descendant of its own
- K200146: HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor (2020), 0 descendants of its own

## Indications for use
is idendical to the Surgitron as a preammendment device such as: Cutting Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthrosgopic Procedures. Blended Cutting and Coagulation Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures. Hemostasis Control of Bleeding, Epilation, Telangiectasia

Source page: https://510kreport.com/device/K992382
Methodology: https://510kreport.com/methodology