← Product Code EFQ · K990974 # VITOP DRESSING (K990974) _Wonder & Bioenergy Hi-Tech America, Inc. · EFQ · Jun 9, 1999 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K990974 ## Device Facts - **Applicant:** Wonder & Bioenergy Hi-Tech America, Inc. - **Product Code:** EFQ - **Decision Date:** Jun 9, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Management of venous cuts, for example, cuts resulting from any shape objects and abrasions, other superficial injuries, superficial wounds, burns (1st and 2nd degree) donor sites, post operative wound. ## Device Story Vitop® Dressing is a wound care product designed for management of superficial injuries and wounds. It is applied topically to the affected area to facilitate healing of venous cuts, abrasions, burns (1st and 2nd degree), donor sites, and post-operative wounds. The device functions as a protective barrier for the wound site. It is intended for use in clinical or home settings, applied by healthcare professionals or patients. The dressing provides physical coverage to the wound, aiding in the management of superficial tissue damage. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Wound dressing material; physical barrier function. No specific materials, energy sources, or software components described. ## 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 0 1999 JUN Wonder Bioenergy Hi-Tech America, Inc. c/o Mr. Arthur King K. Ma D & R Marketing Firm 108 N. Ynez Avenue, Suite 128 Monterey Park, California 91754 K990974 Re: Trade Name: Vitop® Dressing Regulatory Class: Unclassified Product Code: EFQ Dated: March 4, 1999 Received: March 23, 1999 Dear Mr. Ma: 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 (OS) 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 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. {1}------------------------------------------------ ## Page 2 - Mr. Arthur King K. Ma 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, 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}------------------------------------------------ K990974 K990974 510(k) NUMBER (IF KNOWN): DEVICE NAME: vitop® Dressing INDICATION FOR USE: Management of venous cuts, for example, cuts resulting from any shape objects and abrasions, other superficial injuries, superficial wounds, burns (1st and 2nd degree) donor sites, post operative wound. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDEH, Office of Device Evaluation (ODE) Pcotelefo (Division Sign-Off) Division on Ceneral Staturative Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109) OR Over-The Counter-Use (Optional Format 1-2-96) ﺩ → --- **Source:** [https://fda.innolitics.com/device/K990974](https://fda.innolitics.com/device/K990974) **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