# K971711: Somnus Model 215 Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Somnus Medical Technologies, Inc.
- Decided: Jun 24, 1997 after 47 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
No predicates in its family tree.
978 later devices descend from it; 1 cites it directly.
0 of 979 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Somnus Model 215 Electrosurgical Generator: named in the summary without a submission number
- (no number) Erbe ICC 200: named in the summary without a submission number
- (no number) Erbe ICC 50: named in the summary without a submission number
- (no number) VidaMed 50: named in the summary without a submission number
- (no number) VidaMed 7205: named in the summary without a submission number

## Most influential descendants
- K974521: Vnus Closure System (1998), 977 descendants of its own
- K982816: Vnus Closure System (1999), 973 descendants of its own
- K012398: Diomed 15 Diode Laser (2002), 714 descendants of its own
- K022266: Aurora SR (2002), 705 descendants of its own
- K020339: Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System (2002), 695 descendants of its own

## Indications for use
The Somnus Model 215 Electrosurgical Generator, in combination with various Somnus electrodes, is indicated for the coagulation of tissue. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Source page: https://510kreport.com/device/K971711
Methodology: https://510kreport.com/methodology