# K993834: Surgical Lightstic, Models, 180 L, and 180 C

- Pathway: 510(k) (Traditional)
- Applicant: Cardiofocus, Inc.
- Decided: Feb 4, 2000 after 84 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 1 cites it directly.
0 of 33 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) Rare Earth Medical Lightstic Model 180: named in the summary without a submission number
- (no number) Dornier’s Lasertrode Fiber: named in the summary without a submission number
- (no number) Xintec’s Polaris Diode Laser System and Accessories: named in the summary without a submission number
- (no number) CeramOptec’s Ceralas Diode Laser Systems: named in the summary without a submission number

## Most influential descendants
- K011988: Surgical Lightstic 180, Model 180 L, Model 180 C (2001), 31 descendants of its own
- K013901: Malleable Surgical Lightstic 180, Model 180 (1CM-9CM) (2001), 30 descendants of its own
- K022894: Epicor Medical Ablation System (2004), 23 descendants of its own
- K040641: Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-Acc-1 (2004), 22 descendants of its own
- K043579: Atricure Bipolar System (2007), 18 descendants of its own

## Indications for use
The Surgical Lightstic™ 180 is intended to be used as 2 surgical instrument for coagulation of soft tissue in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), and coagulation of soft tissue in the contact mode in both open or closed surgical procedures (with or without handpiece). The Surgical Lightstic™ 180 is indicated for use in medicine and surgery with 980 — 1064 nm wavelength laser energy in the following surgical specialties: General Surgery, Plastic Surgery, and Dermatology.

Source page: https://510kreport.com/device/K993834
Methodology: https://510kreport.com/methodology