← Product Code [FSY](/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY) · K965130

# CHROMOPHARE (K965130)

_Berchtold Holding GmbH · FSY · Jul 14, 1997 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K965130

## Device Facts

- **Applicant:** Berchtold Holding GmbH
- **Product Code:** [FSY](/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY.md)
- **Decision Date:** Jul 14, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4580
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Intended Use

The Surgical light, CHROMOPHARE® D-650, is intended to illuminate locally the operating site on the patient's body with a high light intensity, "cold" light.

## Device Story

CHROMOPHARE® D-650 is a surgical lighting system designed to provide high-intensity, "cold" illumination to a patient's operating site. Used in clinical settings such as operating rooms, the device is operated by surgical staff to ensure visibility during procedures. The system functions by projecting light onto the surgical field, minimizing heat transfer to the patient. It serves as a standard surgical tool to assist clinicians in performing medical interventions by providing clear visualization of the operative area.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Surgical lighting system providing high-intensity, "cold" light. Device is a mechanical/optical illumination system. No software or complex electronic algorithms involved.

## 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.

## 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}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Wolfram Hill
Manager, R&D
Berchtold GmbH and Company
Ludwigstaler Strasse 25
D-78505 Tuttlingen
GERMANY

Re: K965130
CHROMOPHARE®
Regulatory Class: II
Product Code: FSY
Dated: April 11, 1997
Received: April 15, 1997

Dear Mr. Hill:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to

{1}

Page 2 - Mr. Wolfram Hill

comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the *Federal Register*. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

![img-0.jpeg](img-0.jpeg)

Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{2}

BERCHTOLD

16

JULY 11, 1997

# INDICATION FOR USE

The Surgical light, CHROMOPHARE® D-650, is intended to illuminate locally the operating site on the patient's body with a high light intensity, "cold" light.

![img-1.jpeg](img-1.jpeg)

2-11-97

Date

K965130

Prescription Use ☐
(Per 21 CFR 801.109)

![img-2.jpeg](img-2.jpeg)

Berchtold Corporation

1950 Hanahan Road • P.O. Box 60399

800-243-5135 • 803-569-6100

Charleston, SC 29419-0399

Fax: 803-569-6133

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K965130](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K965130)

**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