# K042710: Surgitron Radiolase II

- Pathway: 510(k) (Traditional)
- Applicant: Ellman Int'L, Inc.
- Decided: Apr 7, 2005 after 189 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: 2 generations back to K933157 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992382: Surgitron Radiolase, Ellman Intl., Inc. (1999) Summary page 2.
- K013225: Instaclot for Otc Use, Traumasstat for Prescription Use, Medafor, Inc. (2001) Summary page 2.

## Indications for use
is idendical to the Surgitron as a preamendment device such as: *Cutting Skin and Mucosal Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, Skin Tags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures *Blended Cutting and Coagulation Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures, ENT procedures * Hemostasis Control of Bleeding, Epilation, Telangicctasia Bipolar Pinpoint, Precise Cutting and Coagulation, Pinpoint Hemostasis in any field (Wet or Dry)

Source page: https://510kreport.com/device/K042710
Methodology: https://510kreport.com/methodology