(90 days)
Not Found
No
The summary does not mention AI, ML, image processing, or any data-driven decision-making processes. The device description focuses on the laser technology and user interface.
Yes
The device is indicated for the temporary increase of clear nail in patients with onychomycosis, explicitly stating its purpose to achieve a "therapeutic effect" by incorporating lasers and outputting light at specific wavelengths.
No
The device description states that the `Onycho Laser V' "outputs light at two wavelengths, 405 nm and 635 nm, in order to achieve its therapeutic effect." The intended use also mentions "temporary increase of clear nail," indicating a treatment rather than a diagnostic purpose.
No
The device description explicitly states it is a "compact device that is positioned on the floor" and "incorporates lasers and outputs light," indicating it is a physical hardware device, not software-only.
Based on the provided information, the Onycho Laser V is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the temporary increase of clear nail in patients with onychomycosis. This is a therapeutic use, aiming to treat a condition, not to diagnose it.
- Device Description: The device uses lasers to output light at specific wavelengths for a therapeutic effect. This aligns with a treatment device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of the device analyzing biological samples (like nail clippings or swabs), detecting biomarkers, or providing diagnostic information about the presence or type of onychomycosis.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Onycho Laser V's function is to treat the condition, not to diagnose it.
N/A
Intended Use / 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.).
Product codes
PDZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nail
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
IEC 60601-1 (2020) Medical electrical equipment Part 1: General Requirements for basic safety and essential performance
IEC 60601-1-2 (2020) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-22 (2019) Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1 (2014) Safety of laser products - Part 1: Equipment classification and requirements
Biocompatibility:
The `Onycho Laser V' conforms to the biocompatibility requirements established by the standards.
ISO 10993-5 (2009) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 (2021) Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-23 (2021) Biological evaluation of medical devices - Part 23: Tests for irritation
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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).
2
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
3
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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4
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 with |
| Onychomycosis | |
| Regulation Name | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology | |
| Regulation Number | 21 CFR 878.4810 |
| Classification Product Code | PDZ |
| Device Class | II |
| 510(k) Review Panel | General and Plastic Surgery |
5
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 Patients |
| with Onychomycosis | |
| Requlation Name | Laser surgical instrument for use in general and plastic |
| surgery 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.).
6
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 |
| Laser | |||
| Wavelength | 405nm/635nm (±10%) | 405nm/635nm (±10%) | Identical |
| Output Energy | 405nm: 23mW ± 1.85mW | ||
| 635nm: 17mW ± 1.35mW | 405nm: 23mW ± 1.85mW | ||
| 635nm: 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
| Standards
No. | Standards
Organization | Standard Title | Version | Publication
Year |
|------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------------|
| 60601-1 | IEC | Medical electrical equipment Part 1:
General
Requirements for basic
safety and essential performance | 3.2 | 2020 |
| 60601-1-2 | IEC | Medical electrical equipment - Part 1-
2: General requirements for basic
safety and essential performance -
Collateral Standard: Electromagnetic
disturbances - Requirements and tests | 4.1 | 2020 |
| 60601-2-22 | IEC | Medical electrical equipment - Part 2-
22: Particular requirements for basic
safety and essential performance of
surgical, cosmetic, therapeutic and
diagnostic laser equipment | 4.0 | 2019 |
- The Yonycho Laser V' conforms to the following performance standards:
8
| Standards
No. | Standards
Organization | Standard Title | Version | Publication
Year |
|------------------|---------------------------|------------------------------------------------------------------------------------|---------|---------------------|
| 60825-1 | IEC | Safety of laser products - Part 1:
Equipment classification and
requirements | 3.0 | 2014 |
2) Biocompatibility
The `Onycho Laser V′ conforms to the biocompatibility requirements established by the standards.
| Standards
No. | Standards
Organization | Standard Title | Version | Publication
Year |
|------------------|---------------------------|------------------------------------------------------------------------------------|---------|---------------------|
| 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 |
9
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