← Product Code [FRO](/productcode/FRO) · K261638 # Bonvadis® (K261638) _Oneness Biotech Co., Ltd. · FRO · Jun 17, 2026 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K261638 ## Device Facts - **Applicant:** Oneness Biotech Co., Ltd. - **Product Code:** [FRO](/productcode/FRO.md) - **Decision Date:** Jun 17, 2026 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Indications for Use Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers. ## Device Story Bonvadis® is a non-sterile, semi-viscous topical matrix formulation; applied directly to wound bed by healthcare professional; maintains moist wound environment to support healing; contains Centella Asiatica and Mexican Mint extracts with methyl/propyl parabens as preservatives; supplied in aluminum tube; intended for prescription use. ## Clinical Evidence Bench testing only. Evaluations included shelf-life stability, in-use stability, transepidermal water loss, water retention capacity, biocompatibility, toxicological risk assessment, usability, and transportation testing. Performance specifications (pH, microbial limits per USP<61>/<62>, weight, viscosity, water loss rate, endotoxin) confirmed identical to predicate. ## Technological Characteristics Semi-viscous topical matrix; ingredients include purified water, petrolatum, propylene glycol, cetyl stearyl alcohol, surfactants (span 60, tween 60), and herbal extracts. Non-sterile; stored 15°C-30°C. Packaged in aluminum tube. No electronic or software components. ## Predicate Devices - Bonvadis® Topical Cream ([K251093](/device/K251093.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} **FDA** **U.S. FOOD & DRUG** ADMINISTRATION June 17, 2026 Oneness Biotech Co., Ltd. Angel Hsieh Regulatory Affairs Manager 35f, #66, # 66, Sec. 1, Zhongxiao W. Rd., Zhongzheng Dist., Taipei City Taipei, 100 Taiwan Re: K261638 Trade/Device Name: Bonvadis® Regulatory Class: Unclassified Product Code: FRO Dated: May 18, 2026 Received: May 18, 2026 Dear Angel Hsieh: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. {1} K261638 - Angel Hsieh Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K261638 - Angel Hsieh Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, **MUSTAFA A. MAZHER -S** *For* Yu-Chieh Chiu Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. # Indications for Use 510(k) Number (if known) K261638 Device Name Bonvadis® Indications for Use (Describe) Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} K261638 ## 510(k) Summary ### General Information Preparation Date: May 18, 2026 510(k) Number: K261638 Applicant : Oneness Biotech Co., Ltd. 35F., No. 66, Sec. 1, Zhongxiao W. Rd., Zhongzheng Dist., Taipei City 100, Taiwan, R.O.C. Tel: +886 2 27031098 Contact Person: Angel Hsieh Regulatory Affairs Manager md.regulatory@onenessbio.com.tw ### Device Information Device Name: Bonvadis® Classification Name: Dressing, Wound, Drug Common Name: Wound Dressing Product Codes: FRO Regulation Number: Unclassified ### Predicate Devices Bonvadis® Topical Cream cleared under K251093 on June 9, 2025. Page 1 of 4 {5} K261638 ## Device Description Bonvadis® is a non-occlusive, non-sterile, preserved, semi-viscous topical matrix formulation for prescription use, for single use application directly to the wound bed. Bonvadis® contains methyl and propyl parabens which act as preservatives to inhibit the growth of microorganisms within the product before opening. Ingredients: Purified water, liquid petrolatum, white petrolatum, propylene glycol, cetyl stearyl alcohol, span 60, tween 60, Centella Asiatica extract, Mexican Mint extract, Methyl Paraben, and Propyl Paraben. ## Indications for Use Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers. ## Comparison of Technological Characteristics The subject device is substantially equivalent to its predicate Bonvadis® (K251093). Table 1 compares the subject and predicate devices. The subject device is unchanged from the legally marketed predicate Bonvadis® (K251093) in its intended use, formulation, and design, except for the addition of a 3g package size. There are no changes to the materials of aluminum tube and screw cap, nor other design aspects. The aluminum tube dimensions are modified only to accommodate for the specific filling volume. There is no change to the intended use of the subject device, and the modifications do not raise new safety and effectiveness concerns. Substantial equivalence has been demonstrated through conformity to recognized standards and design verification and validation evaluation. Page 2 of 4 {6} K261638 Table 1 – Comparison of Subject and Predicate Devices | Comparison Feature | Subject Device Bonvadis® | Predicate Device Bonvadis® | | --- | --- | --- | | 510(k) Number | K261638 | K251093 | | Product Code | FRO, Dressing, Wound, Drug | FRO, Dressing, Wound, Drug | | Product Classification | Unclassified | Unclassified | | Intended Use | A topical matrix formulation that maintains a wound environment. | Identical as subject device | | Indications for Use | Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers. | Identical as subject device | | Mechanism of Action | The semi-solid topical matrix formulation provides a moist wound environment that is conducive to healing process. | Identical as subject device | | Sterility Claim | Non-sterile | Identical as subject device | | Delivery System | Topical use on the surface of the wound | Identical as subject device | | How Supplied | 3 g | 15 g | | Storage Condition | 15°C ~ 30°C | Identical as subject device | Standard and Testing Page 3 of 4 {7} K261638 There are no changes to the following non-clinical evaluations: Shelf-life stability, In use stability, Transepidermal water loss (TEWL), Water retention capacity, Biocompatibility, Toxicological risk assessment, Usability, and Transportation testing. These are supported by a verification and validation evaluation summary, confirming that the safety and effectiveness remain substantially equivalent to the predicate device. Additionally, pH value, Microbial limit per USP<61> and USP<62>, Weight, Viscosity, Water loss rate, and Endotoxin testing were conducted for the subject device to demonstrate adherence to the identical performance specifications of the predicate. ### Substantial Equivalence Conclusion The subject device Bonvadis® is substantially equivalent to the previous cleared Bonvadis® (K251093) with the change described within this submission. Bonvadis® has demonstrated that the device is as safe, effective, and performs as well as the predicate devices. Page 4 of 4 --- **Source:** [https://fda.innolitics.com/device/K261638](https://fda.innolitics.com/device/K261638) **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