(467 days)
Not Found
No
The summary describes a laser system with specific wavelengths and indications, and the performance studies focus on verifying physical parameters and compliance with standards. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes
The device is indicated for the treatment of various medical conditions such as benign pigmented lesions, acne scars, and tattoo removal, fulfilling the definition of a therapeutic device.
No
The device description and intended use indicate that the MediYag is a laser system used for treatments such as removing benign pigmented lesions, acne scars, and tattoos. There is no mention of diagnostic functions like image processing, AI, or analysis of patient data for diagnosis.
No
The device description explicitly lists hardware components such as a Main Unit, Articulated Arm, Treatment Probe, and Foot Pedal, indicating it is a physical laser system, not software only.
Based on the provided information, the MediYag device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- MediYag's Function: The MediYag is a laser system that delivers laser energy directly to the patient's skin for the treatment of various skin conditions and tattoo removal. This is a direct therapeutic intervention performed on the body, not a diagnostic test performed on a sample from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic assays, which are hallmarks of IVD devices.
Therefore, the MediYag falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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, Nevus of Ota), and removal of dark ink tattoos (black, blue).
Product codes
GEX
Device Description
The MediYag is a laser system which delivers a laser at a wavelength of 1064nm or 532nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
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: 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.
No clinical study is included in this submission.
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 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.
1
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).
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@;tda.hhs.gov) or phone (1-800-638-2041 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
3
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
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
-
- Date of Preparation
10/01/2024
- Date of Preparation
-
- Sponsor
Medicreations LLC
6370 Annie Oakley Drive, Las Vegas, NV, 89120
Establishment Registration Number: 3012772112
Contact Person: Anthony Hardy Position: Chief Technology Officer Tel: 702-650-0002 Email: anthonyh@medicreations.com
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: | yosemitx@medicreations.com |
5
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
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 | |
|---|---|
| --------------------------------------- | -- |
6
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.
7
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 &
Predicate
| 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 | |||
| Energy | |||
| 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 | |||
| 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.