← Product Code [FSY](/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY) · K083323 # NUVO VERDE LED LIGHTING SYSTEM (K083323) _Nuvo, Inc. · FSY · Jan 28, 2009 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K083323 ## Device Facts - **Applicant:** Nuvo, Inc. - **Product Code:** [FSY](/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY.md) - **Decision Date:** Jan 28, 2009 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 878.4580 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use The proposed Verde LED Surgical Light System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient during surgical and non-surgical procedures. ## Device Story Verde LED Surgical Lighting System is a ceiling-mounted surgical light; provides variable pattern and intensity illumination of surgical field and patient. Used in surgical and non-surgical procedures; operated by clinical staff. Device functions as a light source to improve visibility for healthcare providers during procedures, facilitating clinical decision-making and patient care. No complex data processing or AI/ML components described. ## Clinical Evidence Bench testing only. Performance verified against CEI/IEC 60601-1 and IEC 60601-2-41 requirements for Medical Electrical Equipment. ## Technological Characteristics Ceiling-mounted surgical lighting system; LED-based illumination; variable pattern and intensity control. Complies with CEI/IEC 60601-1 and IEC 60601-2-41 safety standards. ## Regulatory Identification A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient. ## Special Controls *Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. ## Predicate Devices - Aurora LED Series Surgical Light (Skytron) ([K071698](/device/K071698.md)) - Harmony LED-1 Surgical Lighting System (Steris) ([K072072](/device/K072072.md)) - iLED Surgical Lighting System (Trumpf Kreuzer Medizin) ([K061317](/device/K061317.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}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for NUVVO, INC. The logo is in a rectangular shape with rounded corners. The word "NUVVO" is written in a stylized font, with the letters split in half. Below the logo, the words "NUVVO, INC." are written in a smaller, simpler font. JAN 2 8 2009 083323 page ① of ② 13/72 ### 510 (k) SUMMARY Submitter: Nuvo Inc 5368 Kuhl Road Erie, PA 16407 Contact Person: Curt Vander Schaaff Trade Name: Verde LED Surgical Lighting System Light Surgical, Ceiling Mounted Common Name: 21 CFR 878.4580 Classification Number: FSY Product Code: ## Predicate Devices: - Aurora LED Series Surgical Light (Skytron) . K071698 dated July 6, 2007 510 (k): Product Code: FSY . - Harmony LED-1 Surgical Lighting System (Steris) . K072072 dated October 5, 2007 510 (k): Product Code FSY - iLED Surgical Lighting System (Trumpf Kreuzer Medizin) . K061317 dated June 22, 2006 510 (k): Product Code FSY #### Device Description: な The proposed Verde LED Surgical Light System is the next generation variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient during surgical and non-surgical procedures. 5368 KUHL ROAD • ERIE, PENNSYLVANIA 16510 • PHONE 814-899-4220 • FAX 814-899-1410 A member of the Medical Illumination International Group {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for NUVO, INC. The word "NUVO" is written in a stylized font inside of a rounded rectangle. Below the rectangle, the words "N U V O, I N C." are written in a simple font. 14/72 # 483323 #### Intended Use: The proposed Verde LED Surgical Light System is a variable pattern / intensity surgical I ght designed to provide visible illumination of the surgical field and the patient during surgical and non - surgical procedures. #### Description of Safety: The performance of the Verde LED Surgical Lighting System meets the general requirements for safety as defined in CEI/IEC 60601-1 and IEC 60601-2-41 for Medical Electrical Equipment. #### Substantial Equivalence: The proposed Verde LED Surgical Light System is a variable pattern / intensity surgical I ght designed to provide visible illumination of the surgical field and the patient during surgical procedures. The Proposed Device is identical in function, intended use, components, technology and performance to the predicate devices: Aurora LED Series Surgical Light (Skytron) (K071698), Harmony LED-1 Surgical Lighting System (Steris) (K072072), and iLED Surgical Lighting System (Trumpf Kreuzer Medizin) (K061317). The differences between the proposed and predicate devices are limited to differences in design, material, and operational. These differences do not raise any new issues of safety and efficiency ### Performance Testing: 1 Performance testing was conducted to verify that the Verde LED Surgical Lighting System meets the requirements for Medical Electrical Equipment as defined in CEI / IEC 60601-1 and IEC 60601-2-41. 5368 KUHL ROAD ● ERIE, PENNSYLVANIA 16510 ● PHONE 814-899-4220 ● FAX 814-899-1410 A member of the Medical Illumination International Group {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NUVO, Inc. % Mr. Curt Vander Schaaff OA/RA Manager 5368 Kuhl Road Erie, Pennsylvania 16407 JAN 2 8 2009 Re: K083323 Trade/Device Name: The Verde LED Surgical Light System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSY Dated: October 20, 2008 Received: December 2, 2008 Dear Mr. Schaaff: 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 application (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 such 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. 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. {3}------------------------------------------------ Page 2 - Mr. Curt Vander Schaaff This letter will allow you to begin 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/industry/support/index.html. Sincerely vours. Mark N. Millman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications for Use K083323 # 510(k) Number: Unknown Device Name: Indications for Use: The Verde LED Surgical Light System, subjected in this submission is a variable pattern / intensity surgical light designed to provide illumination of the surgical field and patient during surgical and non-surgical procedures. Prescription Use (Per 21 CFR 801.109 X OR Over- the- Counter Use PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Delim Del De 1/29/4 (Division Sign-Off) Division of General, Restorative, and Neurological Devices : 510(k) Number K083323 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K083323](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K083323) **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. 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