(90 days)
The Onycho Laser V is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts, Candida albicans, etc.).
The Onycho Laser V' is a compact device that is positioned on the floor and is operated via a 7.0 inch TFT touch screen for ease of use. The device incorporates lasers and outputs light at two wavelengths, 405 nm and 635 nm, in order to achieve its therapeutic effect.
The provided text is a 510(k) premarket notification for the Onycho Laser V, a device used for the temporary increase of clear nail in patients with onychomycosis.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., x% accuracy, y sensitivity). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (AF Laser, K221363) through technological comparison and adherence to recognized standards. The "performance" in this context refers to the device meeting these standards and having similar technological characteristics and indications for use as the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Onycho Laser V) |
|---|---|
| Identical Indications for Use | "The 'Onycho Laser V' is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)." - Identical to Predicate. |
| Identical Laser Wavelength | 405nm/635nm (±10%) - Identical to Predicate. |
| Identical Output Energy | 405nm: 23mW ± 1.85mW; 635nm: 17mW ± 1.35mW - Identical to Predicate. |
| Similar Output Area | "Line pattern electronically scanned over area of treatment" - Similar to Predicate ("Both devices scan the output beams over the areas being treated."). |
| Identical Output Type | Constant Wave - Identical to Predicate. |
| Similar Operating Time | 0-12 minutes with 1-minute increment - Identical to Predicate (Predicate: 0-12 minutes (±5%) with 1-minute increment). |
| Conformity to Electrical Safety Standards | Conforms to IEC 60601-1 (medical electrical equipment basic safety and essential performance). |
| Conformity to Electromagnetic Compatibility Standards | Conforms to IEC 60601-1-2 (electromagnetic disturbances). |
| Conformity to Laser Safety Standards | Conforms to IEC 60601-2-22 (particular requirements for surgical/therapeutic laser equipment) and IEC 60825-1 (safety of laser products). |
| Conformity to Biocompatibility Standards (for device components with patient contact, if any) | Conforms to ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation). |
| Software Validation | "Software was designed and developed according to a software development process and was verified and validated." |
| No new questions of safety or effectiveness | "The technological parameters of the Onycho Laser V device are either identical or similar to those of the predicate device, and the differences do not raise new types of questions regarding the safety and effectiveness for the proposed indications for use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical study with a test set involving human subjects for assessing the device's efficacy in treating onychomycosis. The demonstration of substantial equivalence relies on non-clinical testing (electrical safety, EMC, laser safety, biocompatibility, software validation) and comparison to a legally marketed predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study with a test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study with a test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a laser for direct treatment of onychomycosis, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical laser device, not an algorithm, and its performance is evaluated through non-clinical testing and comparison to the predicate's established safety and effectiveness.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is defined by the requirements of the international consensus standards (IEC, ISO) for electrical safety, electromagnetic compatibility, laser safety, and biocompatibility. Passing these tests demonstrates conformity to the established safety and performance benchmarks within those specific domains. For the claim of efficacy, it relies on the "ground truth" established by the predicate device's prior clearance for the same indication.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/machine learning device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an eagle emblem, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION" in a smaller font size.
July 22, 2024
TerasysD&C Inc. % Kim Jonghyeon CEO GMSC Co., Ltd. B 612, 66, Cheongcho-ro, Deokyang-gu, Goyang-si Gyeonggi-do, Korea, South
Re: K24116 Trade/Device Name: Onycho Laser V Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: PDZ Dated: April 8, 2024 Received: April 23, 2024
Dear Kim Jonghyeon:
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
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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.
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-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
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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/deviceadvice-comprehensive-regulatory-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.
Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE -○ Date: 2024.07.22
14:49:18 -04'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241116
Device Name Onycho Laser V
Indications for Use (Describe)
The Onycho Laser V is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts, Candida albicans, etc.).
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) |
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uired by 21
1. Date Prepared [21 CFR 807.92(a)(1)]
Apr.06, 2024
2. Submitter's Information [21 CFR 807.92(a)(1)]
- Name of Manufacturer: TerasysD&C. Inc. ●
- Address: Unit 1101~1108, Building N, 249 Sunhwagung-ro, Namyangjusi, Gyeonggi-do, Republic of Korea
- Contact Name: SangHyeop Han
- +82 2-2293-6667 ● Telephone No.:
- Email Address: qc@terasysdnc.com
- TBD 0 Registration No.:
3. Identification of Proposed Device(s) [21 CFR 807.92(a)(2)]
| 510(k) Number | K241116 |
|---|---|
| Trade/Device/Model Name | Onycho Laser V |
| Product Name | Onycho Laser V |
| Common Name | Lasers For Temporary Increase of Clear Nail in Patients withOnychomycosis |
| Regulation Name | Laser surgical instrument for use in general and plasticsurgery and in dermatology |
| Regulation Number | 21 CFR 878.4810 |
| Classification Product Code | PDZ |
| Device Class | II |
| 510(k) Review Panel | General and Plastic Surgery |
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4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
The identified predicate device within this submission is shown as follow;
| 510(k) Number | K221363 |
|---|---|
| Trade/Device/Model Name | AF Laser |
| Product Name | N/A |
| Common Name | Lasers For Temporary Increase of Clear Nail in Patientswith Onychomycosis |
| Requlation Name | Laser surgical instrument for use in general and plasticsurgery and in dermatology |
| Regulation Number | 21 CFR 878.4810 |
| Classification Product Code | PDZ |
| Device Class | II |
| 510(k) Review Panel | General and Plastic Surgery |
These predicate devices have not been subject to a design-related recall.
5. Description of the Device [21 CFR 807.92(a)(4)]
The `Onycho Laser V' is a compact device that is positioned on the floor and is operated via a 7.0 inch TFT touch screen for ease of use. The device incorporates lasers and outputs light at two wavelengths, 405 nm and 635 nm, in order to achieve its therapeutic effect.
6. Indications for Use [21 CFR 807.92(a)(5)]
The 'Onycho Laser V' is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
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7. Technological Comparison [21 CFR 807.92(a)(6)]
Provided below is a table that compares technological characteristics of the Onycho Laser V and the predicate device.
| Proposed Device | Predicate Device | Note | |
|---|---|---|---|
| K Number | K241116 | K221363 | - |
| Manufacturer | TerasysD&C Inc. | ShenB Co Ltd. | - |
| Trade Name | Onycho Laser V | AF Laser | - |
| Product Name | Onycho Laser V | - | - |
| Product Code | PDZ | PDZ | Identical |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| 510(k) Review Panel | General and Plastic Surgery | General and Plastic Surgery | Identical |
| Indications for Use | The 'Onycho Laser V' is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). | The AF Laser device is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). | Identical |
| LaserWavelength | 405nm/635nm (±10%) | 405nm/635nm (±10%) | Identical |
| Output Energy | 405nm: 23mW ± 1.85mW635nm: 17mW ± 1.35mW | 405nm: 23mW ± 1.85mW635nm: 17mW ± 1.35mW | Identical |
| Output area | Line pattern electronically scanned over area of treatment | Line pattern electronically scanned over area of treatment | Both devices scan the output beams over the areas being treated. |
| Output Type | Constant Wave | Constant Wave | Identical |
| Operating Time | 0-12 minutes with 1minute increment | 0-12 minutes (±5%) with 1minute increment | Identical |
| Dimension | 530mm(W) × 410 mm(L) × | 424mm(W) × 308mm(L) × | Similar |
| Proposed Device | Predicate Device | Note | |
| 445mm(H) | 352mm(H) | ||
| Weight | 17kg (1unit) | 17.5kg | Similar |
| Screen | TFT touch 7.0 inch(Diagonal) | LCD Touch Screen | Similar |
[Table 3. Comparison of Proposed Device to Predicate Devices]
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The Onycho Laser V device uses the same basic laser technology as that used by the predicate device. The technological parameters of the Onycho Laser V device are either identical or similar to those of the predicate device, and the differences do not raise new types of questions regarding the safety and effectiveness for the proposed indications for use
8. Non-Clinical Test Summary
The `Onycho Laser V conforms to voluntary standards for electrical safety, electromagnetic compatibility, and other performance. Test results from the following performance standards were provided in support of the safety and effectiveness of the Onycho Laser V device
| StandardsNo. | StandardsOrganization | Standard Title | Version | PublicationYear |
|---|---|---|---|---|
| 60601-1 | IEC | Medical electrical equipment Part 1:GeneralRequirements for basicsafety and essential performance | 3.2 | 2020 |
| 60601-1-2 | IEC | Medical electrical equipment - Part 1-2: General requirements for basicsafety and essential performance -Collateral Standard: Electromagneticdisturbances - Requirements and tests | 4.1 | 2020 |
| 60601-2-22 | IEC | Medical electrical equipment - Part 2-22: Particular requirements for basicsafety and essential performance ofsurgical, cosmetic, therapeutic anddiagnostic laser equipment | 4.0 | 2019 |
- The Yonycho Laser V' conforms to the following performance standards:
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| StandardsNo. | StandardsOrganization | Standard Title | Version | PublicationYear |
|---|---|---|---|---|
| 60825-1 | IEC | Safety of laser products - Part 1:Equipment classification andrequirements | 3.0 | 2014 |
2) Biocompatibility
The `Onycho Laser V′ conforms to the biocompatibility requirements established by the standards.
| StandardsNo. | StandardsOrganization | Standard Title | Version | PublicationYear |
|---|---|---|---|---|
| 10993-5 | ISO | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | 3.0 | 2009 |
| 10993-10 | ISO | Biological evaluation of medical devices - Part 10: Tests for skin sensitization | 4.0 | 2021 |
| 10993-23 | ISO | Biological evaluation of medical devices - Part 23: Tests for irritation | 1.0 | 2021 |
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3) Software Validation
The software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA guidance:
- The content of premarket submissions for software contained in medical devices, on June 14, 2023
9. Conclusion [21 CFR 807.92(b)(3)]
In accordance with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, it is concluded that the `Onycho Laser V′ is substantially equivalent to the predicate device K221363
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.