(70 days)
Not Found
No
The summary describes a laser device with a photochemical mechanism and an LCD screen for operation. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is indicated for use in treating onychomycosis, a medical condition, and is described as a medical laser used to promote the growth of healthy nails, indicating a therapeutic purpose.
No
The "Intended Use" states that the device is "indicated for use for the temporary increase of clear nail in patients with onychomycosis." The "Device Description" also clarifies that the device is "used to treat nail fungus (onychomycosis) and promote the growth of healthy nails." It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a "medical laser" and describes physical components like wavelengths, an LCD screen, and a monitor, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- AF Laser Function: The AF Laser device directly treats the nail using laser energy. It does not analyze any biological samples taken from the patient. Its purpose is therapeutic, not diagnostic.
- Intended Use: The intended use clearly states it's for the "temporary increase of clear nail in patients with onychomycosis," which is a treatment outcome, not a diagnostic result.
- Device Description: The description focuses on the laser technology and its application to the nail, not on analyzing biological samples.
Therefore, based on the provided information, the AF Laser is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.).
Product codes (comma separated list FDA assigned to the subject device)
PDZ
Device Description
The AF Laser is a medical laser used to treat nail fungus (onychomycosis) and promote the growth of healthy nails. The operating mechanism of this device is photochemical reaction that uses two wavelengths -- 635nm and 405nm. The AF laser is a compact, all-in-one device that is intended to be used on the floor and is operated by an intuitive 10.2 inch's wide LCD screen for ease of use. An LCD monitor incorporated into the deck of the device helps the operator check the exact location of treatment area during a procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nail / Toenails
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 following performance data was provided in support of the substantial equivalence determination:
- IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance
- IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility
- IEC 62471:2006 - Photobiological safety of lamps and lamp systems
- IEC 60825-1:2014 - Safety of laser products - Part 1: Equipment classification and requirements
No Clinical testing was conducted as part of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 20, 2022
ShenB Co Ltd % Connie Hoy Consultant Hoy and Associates 1830 Bonnie Way Sacramento, California 95825
Re: K221363
Trade/Device Name: AF Laser 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: May 10, 2022 Received: May 11, 2022
Dear Connie Hoy:
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 (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 located 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
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 and Part 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-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). 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-device-advice-comprehensive-regulatoryassistance/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.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221363
Device Name AF Laser
Indications for Use (Describe)
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.).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510K Summary AF Laser K221363
This 510(K) Summary of safety and effectiveness for the AF Laser is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | ShenB Co Ltd. |
|---|---|
| Address: | Shenb Bldg 148 |
| Seongsui-ro | |
| Seongdong-Gu, Seoul , KR 04796 | |
| Contact Person: | Bora Kim |
| Contact Information: | kimbora@shenb.com |
| +82-70-4814-2978 | |
| Preparation Date: | July 11, 2022 |
| Device Trade Name: | AF Laser - K221363 |
| 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 (Product Code: PDZ) |
| Legally Marketed Predicate Device: | LunulaLaser (K153164) |
| Regulatory Class: | Class II Prescription Use |
| Description of the AF Laser: | The AF Laser is a medical laser used to treat nail fungus |
| (onychomycosis) and promote the growth of healthy nails. | |
| The operating mechanism of this device is photochemical | |
| reaction that uses two wavelengths -- 635nm and 405nm. | |
| The AF laser is a compact, all-in-one device that is intended | |
| to be used on the floor and is operated by an intuitive 10.2 | |
| inch's wide LCD screen for ease of use. An LCD monitor | |
| incorporated into the deck of the device helps the operator | |
| check the exact location of treatment area during a | |
| procedure. | |
| Intended use of AF Laser: | 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.). |
4
510K Summary
AF Laser
K221363
| Performance Testing | The following performance data was provided in support of the substantial equivalence determination: |
|---|---|
| IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance | |
| IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility | |
| IEC 62471:2006 - Photobiological safety of lamps and lamp systems | |
| IEC 60825-1:2014 - Safety of laser products - Part 1: Equipment classification and requirements | |
| Clinical Testing | No Clinical testing was conducted as part of this submission. |
Substantial Equivalence Discussion
Predicate Device Manufacturer Information
| Proposed device | Predicate Device | |
|---|---|---|
| Device Name | AF Laser | LunulaLaser |
| (K153164) | ||
| Manufacturer | ShenB Co., Ltd | |
| 148, Seoungsui-ro | ||
| Seoungdong-gu | ||
| Seoul, Korea | Erchonia Corporation | |
| 2021 Commerce Drive | ||
| McKinney, TX 75069 |
Indications for Use Comparison
| Proposed Device – AF Laser | Predicate Device- LunulaLaser | Comparison |
|---|---|---|
| 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.). | The LunulaLaser™ 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 |
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510K Summary AF Laser K221363
| Specification | AF Laser -
Proposed Device | LunulaLaser-
Predicate Device | Comparison |
|---------------------|------------------------------------------------------------------|------------------------------------------------------------------|------------|
| Laser
Wavelength | 405nm/635nm (±10%) | 405nm/635nm (±10%) | Identical |
| Output Energy | 405nm: 23mW ± 1.85mW
635nm: 17mW ± 1.35mW | 405nm: 23.00 ± 2.00mW
635nm: 17.25 ± 1.25mW | Similar |
| Output area | Line pattern electronically
scanned over area of
treatment | Line pattern electronically
scanned over area of
treatment | Identical |
| Output Type | Constant Wave | Constant Wave | Identical |
| Operating Time | 0-12 minutes (±5%) with 1
minute increment | 0-12 minutes | Identical |
| Dimension | 424mm(W) × 308mm(L) ×
352mm(H) | 300mm(W) x 254mm (L) x
400mm (H) | similar |
| Weight | 17.5kg | 10.43 kg | similar |
| Screen | LCD Touch Screen | LCD Touch screen | Identical |
Discussion
The ShenB AF Laser is identical to its predicate device, the Lunula Laser. They share indications for use, laser wavelengths, and the designs of the device treat patient toenails in the same way. The only difference is slightly different sizes and appearance of the device. Therefore, the ShenB AF Laser is substantially equivalent to the Lunula Laser.