(90 days)
Not Found
No
The device description mentions operation by microprocessor software, but there is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The focus is on the laser technology itself and its physical components.
Yes
Explanation: The device is intended for surgical and aesthetic applications in medical specialties like dermatology, general, and plastic surgery, specifically for tattoo removal. These applications fit the definition of a therapeutic device as they involve treating or correcting medical conditions.
No
Explanation: The device is described as being for "surgical and aesthetic applications" and specifically for "tattoo removal." It does not mention any diagnostic functions. While it references "diagnostic laser equipment" in the testing standards, the intended use and device description do not support a diagnostic purpose.
No
The device description explicitly states it is comprised of hardware components such as a Main Body (optics laser generator, power supply, cooling system, operation panel), Articulated Arm, Handpiece, Foot Switch, Protective Goggles, and Power Supply Cord. While it is operated by microprocessor software, it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) is a laser system used for surgical and aesthetic applications, specifically tattoo removal. It directly interacts with the patient's skin and subcutaneous tissue.
- Lack of Specimen Examination: The device does not examine specimens derived from the human body in vitro. It applies laser energy directly to the patient's body.
- Intended Use: The intended use is for surgical and aesthetic procedures on the patient, not for analyzing biological samples to diagnose or monitor conditions.
The device description and intended use clearly indicate that it is a therapeutic/surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) 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 PICOSECOND Nd:YAG Laser System (PICO PREMIUM ) 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 532nm wavelength of the PICOSECOND Nd: YAG Laser System (PICO PREMIUM ) is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzparick skin types I-III.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) is comprised of the Main Body which includes an optics laser generator, power supply, cooling system, operation panel, etc., and the Articulated Arm, Handpiece, Foot Switch, Protective Goggles, Power Supply Cord, etc. and by applying high voltage to the laser generator 1064nm and 532nm wavelength and emission wavelength of the laser, the maximum output is 5 00mJ. This device is comprised of an Optical Laser Generator (Optics), power supply, chiller, touch LCD panel and switching mode power supply, main control board, air pump, etc., and is operated by microprocessor software.
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 energy.
After turning on the device, set the Wavelength, Fluence, Frequency, Spot Size, etc. to be used then press the Foot Switch in the READY state, the laser will be energized and transferred through the Articulated Arm and handpiece. A cooling system controls the febrility caused by the laser output.
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)
To establish the safety and efficacy of the PICOSECOND Nd: YAG Laser System (PICO PREMIUM), the following evaluations were completed following standards and FDA guidance documents. All acceptance criteria were met. This product fulfills the requirements of:
-
IEC 60601-1:2005/A1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
-
IEC 60601-1-6:2010/A1:2013 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
-
IEC 60601-2-22:2007/A1:2012 Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, and diagnostic laser equipment
-
IEC 60825-1:2014 (third edition) - Safety of laser products - Part 1: Equipment classification and requirements.
Biocompatibility Testing:
- ISO 10993-5:2009 Biological evaluation of medical devices Tests for in vitro cytotoxicity a.
- b. ISO 10993-10:2010 Biological evaluation of medical devices - Tests for skin sensitization
- C. ISO 10993-23:2021 Biological evaluation of medical devices – Tests for skin irritation
Software Verification and Validation Testing:
- a. Applicable parts of FDA Guidance Document "Guidance for the Content of Premarket Submissions for
Software Contained in Medical Devices".
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). 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.
December 21, 2023
IDS, Ltd. % Alexander Henderson Official Correspondent BraunSolutions Regulatory Group 2298 Americus Blvd. East Unit 14 Clearwayer, Florida 33763
Re: K233018
Trade/Device Name: PICOSECOND 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 22, 2023 Received: September 22, 2023
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 (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 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 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 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.
for
Digitally signed by Shlomit Shlomit Halachmi -S Halachmi -S Date: 2023.12.21 14:42:11 -05'00'
Tanisha Hithe Assistant Director
2
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) K233018
Device Name
PICOSECOND Nd:YAG Laser System (PICO PREMIUM)
Indications for Use (Describe)
The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) 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 PICOSECOND Nd:YAG Laser System (PICO PREMIUM ) 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 532nm wavelength of the PICOSECOND Nd: YAG Laser System (PICO PREMIUM ) is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzparick 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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4
510(k) Summary - K233018
December 21, 2023
This summary of 510(k) is being submitted per requirements of 21 CFR Part 807.92
1. 510K Applicant / Submitter:
IDS LTD. RM.908, SJ Techno Ville 278, Beotkkot-ro, Geumcheon-gu, Seoul, Republic of Korea 08511 Contact: Kwang Yeong Ahn, CEO Tel: + 82 - 2 - 20251153 Fax: + 82 - 2 - 2 - 20251154
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: | PICOSECOND Nd: YAG Laser System |
|---|---|
| - Model: | PICO PREMIUM |
| - 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 |
| - Predicate Device | |
| - Trade Name: | Picocaremajesty Nd: YAG Laser System; Won Tech Co., Ltd. |
| - 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:
The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) is comprised of the Main Body which includes an optics laser generator, power supply, cooling system, operation panel, etc., and the Articulated Arm, Handpiece, Foot Switch, Protective Goggles, Power Supply Cord, etc. and by applying high voltage to the laser generator 1064nm and 532nm wavelength and emission wavelength of the laser, the maximum output is 5 00mJ. This device is comprised of an Optical Laser Generator (Optics), power supply, chiller, touch LCD panel and switching mode power supply, main control board, air pump, etc., and is operated by microprocessor software.
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 energy.
After turning on the device, set the Wavelength, Fluence, Frequency, Spot Size, etc. to be used then press the Foot Switch in the READY state, the laser will be energized and transferred through the Articulated Arm and handpiece. A cooling system controls the febrility caused by the laser output.
6. Indications for Use
The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) 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 PICOSECOND Nd: YAG Laser System (PICO PREMIUM) 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 PICOSECOND Nd: YAG Laser System (PICO PREMIUM) 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 | PICOSECOND Nd: YAG Laser System
(PICO PREMIUM)
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 | 532nm mode: 20 to 250mJ
Selectable fluence values are 0.1 to
7.96 J/cm2 at 532nm 1064nm |
| | 1064nm mode: 100 - 500mJ
(Adjustable by 25mJ)
Fluence: 0.1 – 15.92 J/cm2 | mode: 30 to 500mJ
Selectable fluence values are 0.2 to
16.0 J/cm2. at 1064nm |
| 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) | a) Medium: Laser Diode (LD) |
| | b) Wavelength: 635nm | b) Wavelength: 635nm |
| | c) Strength: Less than 5mW | c) Strength: Less than 5mW |
| Pulse Repetition
Rate | 1-10Hz (Adjustable by 1Hz) | 1-10Hz (Max) – Both Modes |
6
| 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) |
There are no significant differences between the PICOSECOND and the predicate device that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics.
8. Performance Data (Non-clinical)
To establish the safety and efficacy of the PICOSECOND Nd: YAG Laser System (PICO PREMIUM), the following evaluations were completed following standards and FDA guidance documents. All acceptance criteria were met. This product fulfills the requirements of:
-
IEC 60601-1:2005/A1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
-
IEC 60601-1-6:2010/A1:2013 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
-
IEC 60601-2-22:2007/A1:2012 Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, and diagnostic laser equipment
-
IEC 60825-1:2014 (third edition) - Safety of laser products - Part 1: Equipment classification and requirements.
9. Biocompatibility Testing:
- ISO 10993-5:2009 Biological evaluation of medical devices Tests for in vitro cytotoxicity a.
- b. ISO 10993-10:2010 Biological evaluation of medical devices - Tests for skin sensitization
- C. ISO 10993-23:2021 Biological evaluation of medical devices – Tests for skin irritation
10. Software Verification and Validation Testing:
- a. Applicable parts of FDA Guidance Document "Guidance for the Content of Premarket Submissions for
Software Contained in Medical Devices".
11. Conclusions:
Based on the information provided in this premarket notification, AMI INC. concludes that the PICOSECOND Nd: YAG Laser System (PICO PREMIUM) is substantially equivalent to the predicate device as described herein in safety and effectiveness.