(264 days)
Not Found
No
The description focuses on the hardware components and basic microprocessor control for setting parameters and triggering the laser, with no mention of AI/ML capabilities or data processing beyond basic device operation.
Yes
The "Summary of Performance Studies" explicitly states "IEC 60601-2-22:2013, Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment," indicating that this device falls under the category of therapeutic laser equipment.
No
The "Intended Use / Indications for Use" section states that the device is intended for "surgical and aesthetic applications" and specifically for "tattoo removal." Laser systems used for the stated purposes are therapeutic or aesthetic devices, not diagnostic devices.
No
The device description explicitly lists numerous hardware components including the main body, optics laser generator, power supply, cooling system, articulated arm, handpiece, foot-switch, protective goggles, and power supply cord. It also describes the physical mechanism of laser generation. While it mentions a microprocessor and software verification and validation, the core of the device is hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery," specifically for "tattoo removal." This is a therapeutic and aesthetic application, not a diagnostic one.
- Device Description: The description details a laser system that emits light to interact with tissue (tattoo ink). It does not describe a device that analyzes biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Performance Studies: The performance studies listed focus on safety standards for medical electrical equipment and lasers, as well as biocompatibility and software validation. There are no studies related to the analysis of biological samples or diagnostic accuracy metrics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PICO LEGEND Nd: Y AG Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
-The 1064nm wavelength of the PICO LEGEND Nd: Y AG Laser System is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).
-The 532mm wavelength of the PICO LEGEND Nd:YAG Laser System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
This device comprises the main body, including the optics laser generator, power supply, cooling system, operation panel, articulated arm, handpiece, foot-switch, protective goggles, power supply cord, etc. Applying a high voltage to the laser generator generates 1064nm and 532nm laser emission wavelengths. The maximum output is 500mJ.
The optical laser generator (optics), power supply, chiller, touch LCD panel, switching mode power supply, main control board, air pump, etc., are operated by a microprocessor.
The Optical Laser Generator (Optics) is comprised of Nd: YAG Rod, which is the solid laser medium, Flash lamp for optical generation, various Reflector for optical transmission, etc., and permits high voltage in flash lamp connected with power supply and operates to generate laser. After turning on the device, once the Wavelength, frequency, Frequency, Spot Size, etc., have been set, press the Foot Switch in the READY state; the laser energy will be produced and transferred through the Articulated Arm and handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin and subcutaneous tissue
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)
Performance Testing:
-IEC 60601-1:2005/A1:2012, Medical electrical equipment Part1: General requirements for basic safety and essential performance.
-IEC 60601-1-2:2014, Medical electrical equipment Part1-2: General requirements for basic safety and essential performance.
-IEC 60601-1-6:2010/A1:2013, Medical electrical equipment Part 1-6; General requirements for safety -Collateral Standard: Usability.
-IEC 60601-2-22:2013, 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. -Bench testing to show that the device delivers set energy parameters within specifications
Biocompatibility Testing:
-ISO 10993-5:2009 Biological evaluation of medical devices - Tests for in vitro cytotoxicity -ISO 10993-10:2010 Biological evaluation of medical devices - Tests for skin sensitization -ISO 10993-23:2021 Biological evaluation of medical devices – Tests for skin irritation
Software Verification and Validation Testing:
-Applicable parts of FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
Clinical Testing: No clinical testing provided.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 12, 2024
AMI Inc. % Alexander Henderson Official Correspondent BraunSolutions Regulatory Group 2298 Americus Blvd. East Unit 14 Clearwater, Florida 33763
Re: K233007
Trade/Device Name: PICO LEGEND Nd:YAG Laser System 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: September 26, 2023 Received: May 13, 2024
Dear Alexander Henderson:
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/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.
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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.
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-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 (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.
Tanisha L-Digitally signed by Hithe -S - Date: 2024.06.12 20:12:51 -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) K233007
Device Name PICO LEGEND Nd:YAG Laser System
Indications for Use (Describe)
The PICO LEGEND Nd: Y AG Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
-The 1064nm wavelength of the PICO LEGEND Nd: Y AG Laser System is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).
-The 532mm wavelength of the PICO LEGEND Nd:YAG Laser System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
| 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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510(k) Summary
K233007
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR Part 807.92
Date of preparation: 6/10/2024
1. 510K Applicant / Submitter:
AMI INC. Attn: Ms. Hae Youn, Lee, CEO RM.1412, SJ Techno Ville, 278, Beotkkot-ro, Geumcheon-gu, Seoul, 08511, Republic of Korea Tel: +82-2-3281-9091 Fax: +82-2-3281-8011
2. Submission Contact Person
BraunSolutions Regulatory Group Attn: Alexander B. Henderson 2298 Americus Blvd. East, Unit #14 Clearwater, Florida USA 33763 Phone: 1-720-589-4939 Email: BraunSolutions@live.com
3. Subject Device
| - Trade Name: | PICO LEGEND Nd: YAG Laser System |
|---|---|
| - Classification Name: | General & Plastic Surgery/Dermatology |
| - Regulation Number: | 21 CFR 878.4810 |
| - Regulation Name: | Laser Surgical Instrument For Use In General And Plastic Surgery and in |
| Dermatology | |
| - Regulatory Class: | II |
| - Product Code: | GEX |
| 4. Predicate Device | |
| - Trade Name: | Picocaremajesty Nd: YAG Laser System; Won Tech Co., Ltd. |
| - 510(k) Number: | K212127 |
| - Regulation Number: | 21 CFR 878.4810 |
| - Regulation Name: | Laser Surgical Instrument For Use In General And Plastic Surgery and in |
| Dermatology | |
| - Regulatory Class: | II |
| - Product Code: | GEX |
5. Description:
This device comprises the main body, including the optics laser generator, power supply, cooling system, operation panel, articulated arm, handpiece, foot-switch, protective goggles, power supply cord, etc. Applying a high voltage to the laser generator generates 1064nm and 532nm laser emission wavelengths. The maximum output is 500mJ.
The optical laser generator (optics), power supply, chiller, touch LCD panel, switching mode power supply, main control board, air pump, etc., are operated by a microprocessor.
5
The Optical Laser Generator (Optics) is comprised of Nd: YAG Rod, which is the solid laser medium, Flash lamp for optical generation, various Reflector for optical transmission, etc., and permits high voltage in flash lamp connected with power supply and operates to generate laser. After turning on the device, once the Wavelength, frequency, Frequency, Spot Size, etc., have been set, press the Foot Switch in the READY state; the laser energy will be produced and transferred through the Articulated Arm and handpiece.
6. Indications for Use
The PICO LEGEND Nd:YAG Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
-
The 1064nm wavelength of the PICO LEGEND Nd:YAG Laser System is indicated for tattoo removal for dark colored tattoo inks and multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).
-
The 532nm wavelength of the PICO LEGEND Nd:YAG Laser System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
7. Comparison to Predicate Device - Technical Characteristics
Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)].
| Characteristics | PICO LEGEND Nd: YAG Laser System
Proposed Device | PICOCAREMAJESTY
K212127 - Predicate Device |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Anatomical Site | Skin and subcutaneous tissue | Skin and subcutaneous tissue |
| Wavelength | 532 or 1064nm (+/-10%) | 532 or 1064nm (+/-10%) |
| Pulse Width | 300 ps - Both Modes | 532nm mode: 300-400 ps
1064nm mode: 300-400 ps |
| Pulse Energy | 532nm mode: 50 - 250mJ
(Adjustable by 25mJ)
Fluence: 0.1 – 7.96 J/cm2
1064nm mode: 100 - 500mJ
(Adjustable by 25mJ)
Fluence: 0.1 – 15.92 J/cm2 | 532nm mode: 20 to 250mJ
Fluence: 0.1 to 7.96 J/cm2
1064nm mode: 30 to 500mJ
Fluence: 0.2 to 16.0 J/cm2 |
| Spot Size | 2mm - 10mm (Adjustable by 1mm)
- Both Modes | 532nm mode: (2 to 10mm)
Step: 1mm
1064nm mode: (2 to 10mm)
Step: 1mm |
| Aiming Beam | a) Medium: Laser Diode (LD)
b) Wavelength: 635nm
c) Strength: Less than 5mW | a) Medium: Laser Diode (LD)
b) Wavelength: 635nm
c) Strength: Less than 5mW |
| Pulse Repetition
Rate | 1-10Hz (Adjustable by 1Hz) | 1-10Hz (Max) – Both Modes |
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| Laser Delivery
| Setup | Articulated Arm with Handpiece | Articulated Arm with Handpiece |
|---|---|---|
| Patient Contact | ||
| Material | Aluminum (Handpiece Tip) | |
| Biocompatibility | ||
| (CAS No. 7429-90-5) | Aluminum (Handpiece Tip) | |
| Biocompatibility (Cas | ||
| No. 7429-90-5) |
The above table shows that the technical specifications of the subject and predicate devices are comparable.
8. Performance Data (Non-clinical)
To establish the safety and efficacy of the PICO LEGEND Nd:YAG Laser System, the following evaluations were completed following standards and FDA guidance documents. All acceptance criteria were met:
Performance Testing:
-IEC 60601-1:2005/A1:2012, Medical electrical equipment Part1: General requirements for basic safety and essential performance.
-IEC 60601-1-2:2014, Medical electrical equipment Part1-2: General requirements for basic safety and essential performance.
-IEC 60601-1-6:2010/A1:2013, Medical electrical equipment Part 1-6; General requirements for safety -Collateral Standard: Usability.
-IEC 60601-2-22:2013, 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. -Bench testing to show that the device delivers set energy parameters within specifications
Biocompatibility Testing:
-ISO 10993-5:2009 Biological evaluation of medical devices - Tests for in vitro cytotoxicity -ISO 10993-10:2010 Biological evaluation of medical devices - Tests for skin sensitization -ISO 10993-23:2021 Biological evaluation of medical devices – Tests for skin irritation
Software Verification and Validation Testing:
-Applicable parts of FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
9. Clinical Testing: No clinical testing provided.
10. Conclusions:
Based on the information provided in this premarket notification, AMI INC. concludes that the PICO LEGEND Nd:YAG Laser System is substantially equivalent to the predicate device described herein regarding safety and effectiveness.