510(k) Report

510(k) · Cleared

Cleared

Surgical Lightstic 180, Model 180 L, Model 180 C

K011988510(k) TraditionalCleared Sep 20, 200186-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cardiofocus, Inc. · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Cleared on Sep 20, 2001 as substantially equivalent to K993834 (Cardiofocus, Inc., 2000) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1998. 31 later devices descend from it.

Decided
Sep 20, 2001
Review
86 days
Class
Class II
Product code
OCL
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K980668 (1998). 2 ancestors in all. 31 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2004: 3 descendants cleared2001: 1 descendant cleared2005: 1 descendant cleared2007: 2 descendants cleared2006: 2 descendants cleared2008: 4 descendants cleared2011: 1 descendant cleared2010: 2 descendants cleared2009: 2 descendants cleared2012: 2 descendants cleared2019: 2 descendants cleared2018: 1 descendant cleared2021: 2 descendants cleared2022: 2 descendants cleared2020: 1 descendant cleared2025: 1 descendant cleared2024: 2 descendants clearedK980668 · CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790 · Cryomedical Sciences, Inc. · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 6 descendants3 generations forward: 6 descendants4 generations forward: 10 descendants5 generations forward: 6 descendants6 generations forward: 1 descendant K980668 · CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790 · Cryomedical Sciences, Inc. · 19980+5
  1. Root · 1 generation backK980668 CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790Cryomedical Sciences, Inc. · 1998
  2. This deviceK011988 Surgical Lightstic 180, Model 180 L, Model 180 CCardiofocus, Inc. · 2001
  3. Descendant · cites it directly · 30 of its ownK013901 Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc. · 2001
  4. Descendant · 2 generations on · 23 of its ownK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
  5. Descendant · cites it directly · 22 of its ownK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
  6. Descendant · 2 generations on · 18 of its ownK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
  7. Descendant · 3 generations on · 10 of its ownK080509 Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP…Medtronic, Inc. · 2008

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2001: 12004: 32005: 12006: 22007: 22008: 42009: 22010: 22011: 12012: 22018: 12019: 22020: 12021: 22022: 22024: 22025: 1
2001high 4 (2008) · low 0 (2002)2026

Most influential descendants

Showing 5 of 31 · See all
  • K013901Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc. · 2001 · cites it directly30descendants
  • K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004 · 2 generations on23descendants
  • K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc. · 2004 · cites it directly22descendants
  • K043579Atricure Bipolar SystemAtriCure, Inc. · 2007 · 2 generations on18descendants
  • K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc. · 2008 · 3 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K980668CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790Cryomedical Sciences, Inc.1998—
0 (this device)K011988Surgical Lightstic 180, Model 180 L, Model 180 CCardiofocus, Inc.2001—
+1K013901Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc.2001—
+2K022894Epicor Medical Ablation SystemEpicor Medical, Inc.2004—
+1K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9…Epicor Medical, Inc.2004—
+2K043579Atricure Bipolar SystemAtriCure, Inc.2007—
+3K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation…Medtronic, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200430
200510
200620
200720
200840
200920
201020
201110
201220
201810
201920
202010
202120
202220
202420
202510
FIG. 1 — Lineage of K011988, 1998–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OCL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OCL device

  1. #1 K252056 Isolator® Synergy™ EnCompass Clamp and Guide…score 13.0 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K993834Surgical Lightstic, Models, 180 L, and 180 C
Summary page 1
…Name Surgical Laser Instrument Accessories Predicate Devices The Surgical Lightstic 180 for use in cardiac tissue is identical to the current Surgical Lightstic 180 (K993834), and substantially equivalent for indications for use in cardiac tissue to Cryomedical Sciences, Inc. CMS Blizzard K980668 . ==…
Cardiofocus, Inc.2000—
*K980668CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790
Summary page 1
…ntical to the current Surgical Lightstic 180 (K993834), and substantially equivalent for indications for use in cardiac tissue to Cryomedical Sciences, Inc. CMS Blizzard K980668 . icoitg# 2> Intended Use The Surgical LightsticTM 180 is intended to be used as a surgical instrument for coag…
Cryomedical Sciences, Inc.1998—

What descends from it? (31)

See all 31

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013901Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc.200130
K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc.200422

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K013901 (Cardiofocus, Inc., 2001) has gone furthest, with 30 descendants of its own.

How does its category compare?

All OCL devices

OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCL

1in 2025

2007: 32008: 52009: 22010: 22011: 22012: 62013: 22014: 12017: 12018: 22019: 62020: 12021: 22022: 22024: 12025: 1
2007high 6 (2012) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCL

85in 2019

2007: 139 days median2008: 81 days median2012: 75 days median2019: 85 days median
2007high 139 (2007) · low 75 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OCL

1in 2021

2008: 12009: 12010: 22013: 12016: 12019: 42020: 42021: 1
2007high 4 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OCL

46in 2025

2009: 82010: 232011: 212012: 212013: 132014: 152015: 312016: 762017: 552018: 612019: 492020: 372021: 632022: 592023: 992024: 592025: 46
2007high 99 (2023) · low 0 (2007)2025

MAUDE reports naming product code OCL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007313900
200858110
20092—18
20102—223
20112—021
2012675021
20132—113
20141—015
20150—031
20160—176
20171—055
20182—061
2019685449
20201—437
20212—163
20222—059
20230—099
20241—059
20251—046
20260—0—

What is it indicated for?

Expanded for: Coagulation of Cardiac Tissue

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Cardiofocus, Inc.

21 FDA decisions under this applicant name. See the company

  • P150026/S015HeartLight Catheter, HeartLight X3 Console V2Cardiofocus, Inc. · 2023
  • P150026/S014HeartLight Catheter, HeartLight X3 Console V2Cardiofocus, Inc. · 2023
  • P150026/S013HeartLight® X3 Catheter with Excalibur Balloon™Cardiofocus, Inc. · 2022
  • P150026/S012HeartLight X3 Endoscopic Ablation SystemCardiofocus, Inc. · 2021
  • P150026/S011HeartLight Catheter and HeartLight ConsoleCardiofocus, Inc. · 2020

Recent decisions in OCL

The OCL category page

  • K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc. · 2025
  • K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc. · 2024
  • K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator®…AtriCure, Inc. · 2022
  • K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation DeviceMedtronic, Inc. · 2022
  • K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc. · 2021

https://510kreport.com/device/K011988 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011988: Surgical Lightstic 180, Model 180 L, Model 180 C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011988

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026