MEDIYAG

K231948 · Medicreations, LLC · GEX · Oct 9, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K231948
• Device Name: MEDIYAG
• Applicant: Medicreations, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 9, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MediYag is indicated for: 532nm wavelength: treatment of benign pigmented lesions (Lentigines, Birthmark: Cafe-Au-Lait). 1064nm wavelength: treatment of acne scars, benign pigmented lesions (Nevus of Ota), and removal of dark ink tattoos (black, blue).

Device Story

MediYag is a Q-switched Nd:YAG laser system for dermatological procedures. Device consists of main unit with human-machine interface, articulated arm, treatment probe, and foot pedal. Operator (physician/clinician) selects 532nm or 1064nm wavelength based on target condition (pigmented lesions, acne scars, or tattoos). Foot pedal controls laser light output delivered via probe to patient skin. System provides non-invasive treatment; energy parameters (energy, repetition rate, pulse width, spot size) are adjustable. Device intended for clinical use to improve skin appearance or remove tattoos.

Clinical Evidence

No clinical data. Bench testing only, including verification of energy output, repetition rate, pulse width, and spot size against design specifications. Compliance with IEC 60601-1, IEC 60601-1-2, and ISO 14971 confirmed.

Technological Characteristics

Q-switched Nd:YAG laser; wavelengths 532nm/1064nm. Output energy 1064nm (100-1300 mJ), 532nm (50-450 mJ). Repetition rate 1-10 Hz; pulse width 5 ns; spot size 2-10 mm. Standards: IEC 60601-1:2012, IEC 60601-1-2:2014, ISO 14971:2019. Patient-contacting materials identical to predicate K161926.

Indications for Use

Indicated for patients requiring treatment of benign pigmented lesions (Lentigines, Cafe-Au-Lait, Nevus of Ota), acne scars, or removal of dark ink tattoos (black, blue) using 532nm or 1064nm laser wavelengths.

Regulatory Classification

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.

Predicate Devices

• ND YAG Q-switch Laser Therapy Machine (K161926)
• ND:YAG Laser Therapy Systems (K193477)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym in a blue square, followed by the full name "U.S. Food & Drug Administration" in blue text. The symbol of the Department of Health & Human Services is a stylized representation of a human figure.

October 9, 2024

Medicreations LLC Anthony Hardy Chief Technology Officer 6370 Annie Oakley Drv Las Vegas, Nevada 89120

Re: K231948

Trade/Device Name: Mediyag 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: GEX Dated: June 14, 2024 Received: September 19, 2024

Dear Anthony Hardy:

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 (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/cdrb/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.

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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 OS 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.

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-device-advicecomprehensive-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-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@;tda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

TANISHA TANISHA LITHE -S L. HITHE -S 09:54:32 -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) K231948

Device Name MediYag

Indications for Use (Describe) The MediYag is indicated for:

532nm wavelength: treatment of benign pigmented lesions (Lentigines, Birthmark: Cafe-Au-Lait).

1064nm wavelength: treatment of acne scars, benign pigmented lesions (Nevus of Ota), and removal of dark ink tattoos (black, blue).

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary - K231948

Image /page/4/Picture/1 description: The image shows a logo for Medicreations. The logo features the letters 'M' and 'C' in a stylized, interconnected design. The letters are rendered in a dark purple color, and the word 'MEDICREATIONS' is written in smaller, sans-serif font below the letters.

This 510(k) Summary is being submitted for Medicreations LLC's MediYag Special 510(k) in accordance with requirement of 21 CFR 807.92.

The assigned 510(k) Number: K231948

- 1. Date of Preparation
10/01/2024

- 2. Sponsor
### Medicreations LLC

6370 Annie Oakley Drive, Las Vegas, NV, 89120

Establishment Registration Number: 3012772112

Contact Person: Anthony Hardy Position: Chief Technology Officer Tel: [phone] Email: [e-mail]

### 3. Submission Correspondent

### Medicreations LLC

6370 Annie Oakley Drive, Las Vegas, NV, 89120

| Name: | Yosemit Xolalpa Rosales |
|-----------|----------------------------|
| Position: | Lead Systems Engineer |
| Tel: | 702-650-0002 |
| Email: | [e-mail] |

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# 510(k) Summary – K231948

Image /page/5/Picture/1 description: The image shows a logo with the letters 'MC' in a stylized font. The 'M' is formed by two diagonal lines connected at the top, and the 'C' is a simple curved shape. The letters are in a dark purple color. Below the letters, the word 'MEDICREATIONS' is written in smaller, sans-serif font.

### Proposed Device Identification 4.

Trade Name: MediYag Common Name: Powered Laser Surgical Instrument Model: MY A

# Regulatory Information

| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in<br>dermatology |
|----------------------|----------------------------------------------------------------------------------------|
| Classification: | Class II |
| Product Code: | GEX |
| Regulation Number: | 21 CFR 878.4810 |
| Review Panel: | General & Plastic Surgery |

## Indications for Use Statement:

The MediYag is indicated for:

532nm wavelength: treatment of benign pigmented lesions (Lentigines, Birthmark; Cafe-Au-Lait).

1064nm wavelength: treatment of acne scars, benign pigmented lesions (Nevus, Nevus of Ota), and removal of dark ink tattoos (black, blue).

#### న్. Device Description

The MediYag is a laser system which delivers a laser at a wavelength of 1064nm or 532nm.

| Component Name | Function |
|-----------------|------------------------------------------------|
| Main Unit | Main human-machine interface |
| Articulated Arm | Articulated arm for holding of Treatment Probe |
| Treatment Probe | Laser Delivery |
| Foot Pedal | Control light output |

| Table 1: Main Components Introduction | |
|---------------------------------------|--|
|---------------------------------------|--|

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# 510(k) Summary – K231948

Image /page/6/Picture/1 description: The image shows a logo for Medicreations. The logo features the letters 'M' and 'C' in a stylized, interconnected design. The letters are rendered in a dark purple color. Below the letters, the word 'MEDICREATIONS' is written in a smaller, sans-serif font, also in dark purple.

### Predicate Device Identification 6.

## Primary Predicate Device:

| 510(k) Number: | K161926 |
|----------------|---------------------------------------|
| Product Name: | ND YAG Q-switch Laser Therapy Machine |
| Manufacturer: | Beijing ADSS Development Co., Ltd |

## Secondary Predicate Device:

| 510(k) Number: | K193477 |
|----------------|-----------------------------------------|
| Product Name: | ND:YAG Laser Therapy Systems |
| Manufacturer: | Beijing KES Biology Technology Co., Ltd |

### Non-Clinical Testing 7.

Non-clinical tests were conducted to verify that the proposed device met all design specifications. Validation testing was performed to confirm that the subject device operates according to the noted specifications for energy output, repetition rate, pulse width, and spot size. The test results demonstrated that the proposed device complies with the following standards:

- > IEC 60601-1:2012 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance;
- > IEC 60601-1-2:2014 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.

> ISO 14971:2019 Medical devices - Application of risk management to medical devices

#### Software Verification and Validation Testing 7a.

The test method outlined for the MediYag device system software is a comprehensive and structured procedure that evaluates the various aspects of its functionality, safety, and performance, including interaction and observation methods of the display functions, interface functions, factory parameters, and water flow and temperature display as well as alarm and cooling effect functions.

### Clinical Testing 8.

No clinical study is included in this submission.

#### Biocompatibility 9.

No biocompatibility testing was necessary in this submission since the patient-contacting portions of the device are identical to those cleared under K161926.

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# 510(k) Summary – K231948

Image /page/7/Picture/1 description: The image shows a logo for a company called "MEDICREATIONS". The logo features the letters "MC" in a stylized, sans-serif font. The letters are purple and are stacked on top of each other. The word "MEDICREATIONS" is written in a smaller font below the letters "MC".

### Substantially Equivalent (SE) Comparison 10.

| Device &<br>Predicate<br>Devices | K231948 | K161926 | K193477 |
|----------------------------------|----------------------|----------------------|--------------------|
| General Device Characteristics | | | |
| Product Code | GEX | GEX | GEX |
| Class | II | II | II |
| Regulation | 878.4810 | 878.4810 | 878.4810 |
| Laser Medium | Nd: YAG | Nd: YAG | Nd: YAG |
| Laser Type | Q-switched | Q-switched | Q-switched |
| Wavelength | 1064 nm | 1064 nm | 1064 nm |
| | 532 nm | 532 nm | 532 nm |
| Output Energy | 1064 nm: 100-1300 mJ | 1064 nm: 100-1000 mJ | 1064 nm: 1600 mJ |
| | 532 nm: 50-450 mJ | 532 nm: 50-500 mJ | 532 nm: 400 mJ |
| Maximum<br>Energy<br>Density | 1064 nm: 41.4 J/cm2 | 1064 nm: 31.8 J/cm2 | 1064 nm: 51 J/cm2 |
| | 532 nm: 14.3 J/cm2 | 532 nm: 15.9 J/cm2 | 532 nm: 12.7 J/cm2 |
| Spot Size | 2-10 mm | 2-10 mm | 2-10 mm |
| Pulse Width | 5 ns | 5 ns | 5 - 10 ns |
| Repetition<br>Rate | 1-10 Hz | 1-10 Hz | 1-6 Hz |

Table 2: Comparison

### Substantially Equivalent Conclusion 11.

The differences in the indications for use and technological characteristics between the subject and predicate devices do not raise new types of questions regarding safety and effectiveness, and the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.