← Product Code [OCL](/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL) · K011988 # SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C (K011988) _Cardiofocus, Inc. · OCL · Sep 20, 2001 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94surgical-devices/OCL/K011988 ## Device Facts - **Applicant:** Cardiofocus, Inc. - **Product Code:** [OCL](/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL.md) - **Decision Date:** Sep 20, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Surgical Lightstic" 180 is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), in the contact or non-contact mode in both open or closed surgical procedures (with or without handpiece). The Surgical Lightstic™ 180 is indicated for use in laser medicine and surgery with 980-1064 nm wavelength laser energy in the following surgical specialties: general surgery, cardiothoracic surgery(recommended 980nm), plastic surgery and dermatology. ## Device Story Surgical Lightstic 180 is a fiber laser accessory used for soft tissue coagulation. It delivers laser energy (980-1064 nm) to target tissue in contact or non-contact modes. The device is used in open or closed surgical procedures, potentially in conjunction with endoscopic equipment (e.g., laparoscopes, bronchoscopes). It is operated by surgeons in clinical settings such as ORs. The device acts as a delivery conduit for laser energy, enabling precise coagulation of soft tissue, including cardiac tissue. By facilitating controlled thermal coagulation, it assists surgeons in achieving hemostasis or tissue modification, thereby supporting surgical outcomes. ## Clinical Evidence No clinical data provided; performance data not required. ## Technological Characteristics Fiber laser accessory for 980-1064 nm wavelength laser energy delivery. Designed for contact or non-contact soft tissue coagulation. Compatible with various endoscopic instruments. ## Regulatory Identification An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current. ## Predicate Devices - Surgical Lightstic 180 ([K993834](/device/K993834.md)) - Cryomedical Sciences, Inc. CMS Blizzard ([K980668](/device/K980668.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # SEP 2 0 2001 K011988 i/2 #### 510(k) Summary # Surgical Lightstic™ 180 This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR \$807 for the Surgical Lightstic" 180. #### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared | Joseph Curtis
10 Commerce Way
Norton, MA 02766 | | |------------------------------------------------------|----------------| | Telephone: | (508) 285-1700 | | Facsimile: | (508) 285-7579 | | Contact Person: | same | | Date Prepared: | June 22, 2001 | #### Name of Device and Name/Address of Sponsor Surgical Lightstic™ 180 CardioFocus, Inc. 10 Commerce Way Norton, MA 02766 ## Common or Usual Name Laser Tissue Coagulator #### Classification 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 . {1}------------------------------------------------ K011988 4/2 ## Intended Use The Surgical Lightstic" 180 is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), in the contact or non-contact mode in both open or closed surgical procedures (with or without handpiece). The Surgical Lightstic™ 180 is indicated for use in laser medicine and surgery with 980-1064 nm wavelength laser energy in the following surgical specialties: general surgery, cardiothoracic surgery(recommended 980nm), plastic surgery and dermatology. # Technological Characteristics and Substantial Equivalence From a clinical perspective and comparing design specifications, the CardioFocus Surgical Lightstic"" 180 and the predicate device are substantially equivalent and have the same intended use. CardioFocus, Inc. believes the minor differences of the CardioFocus Surgical Lightstic" 180 and its predicate fiber laser accessories should not raise any concerns regarding the overall safety and effectiveness. #### Performance Data None required. {2}------------------------------------------------ Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 1 2008 CardioFocus, Inc. c/o Mr. Joseph Curtis Vice President Clinical and Regulatory Aff airs 10 Commerce Way Norton, MA 02766 Re: K011988 Trade/Device Name: Surgical Lightstic TM 180 Regulation Number: 21 CFR 878.4810 Regulation name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II (two) Product Code: OCL Dated: June 25, 2001 Received: June 26, 2001 Dear Mr. Curtis: This letter corrects our substantially equivalent letter of September 20, 2001. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ #### Page 2 - Mr. Joseph Curtis Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. el.moll. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use Statement Kolla88 510(k) Number (if known): Device Name: Surgical Lightstic™ 180 Indications For Use: Expanded for: Coagulation of Cardiac Tissue These are additional indications to the already cleared indications for market Note: release in K993834. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR §801.109) OR Over-The-Counter Use SN (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K011988 38 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94surgical-devices/OCL/K011988](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94surgical-devices/OCL/K011988) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com