(28 days)
Not Found
No
The summary describes a laser system controlled by an embedded processor, but there is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes.
The device is indicated for tattoo removal and treatment of benign pigmented lesions, which are therapeutic applications. Additionally, the Summary of Performance Studies explicitly mentions "surgical, cosmetic, therapeutic and diagnostic laser equipment" in relation to IEC 60601-2-22: 2007 (Third Edition) + A1:2012, confirming its therapeutic classification.
No
This device is a PicoLO laser system intended for surgical and aesthetic applications, specifically for tattoo removal and treatment of benign pigmented lesions. It is a therapeutic device, not a diagnostic one. While one of the performance studies mentions "diagnostic laser equipment" in the context of a standard (IEC 60601-2-22), the explicit intended use and device description do not indicate any diagnostic function.
No
The device description explicitly states it is a "multi-wavelength, pulsed laser system" and lists physical components like a "main body, color touch screen, articulated arm, hand piece and foot switch." This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the PicoLO laser system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states "surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery" and specifically mentions "tattoo removal" and "treatment of benign pigmented lesions." These are therapeutic and aesthetic procedures performed directly on the patient's body.
- Device Description: The description details a laser system that delivers thermal energy to the epidermis and dermis. This is a physical intervention on the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The PicoLO system does not perform any such analysis of specimens.
- Performance Studies: The performance studies focus on the safety and performance of the laser system itself and its compliance with standards related to medical devices used for treatment, not on the accuracy or reliability of diagnostic results from analyzing specimens.
Therefore, the PicoLO laser system is a therapeutic/aesthetic medical device, not an IVD.
N/A
Intended Use / Indications for Use
PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064nm
The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
532nm
The 532nm wavelength of the PicoLO laser system is indicated for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The PicoLO laser system is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm). The PicoLO Nd: YAG Picosecond Laser System consists of a set of Q-switched Nd:YAG lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.
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
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)
Non-clinical tests: Testing conducted on the PicoLO Nd: YAG Picosecond Laser System shows that it refers to the relevant mandatory performance standards for laser products 21 CFR 1040.10 and 1040.11. Other performance, such as electromagnetic compliance, etc, were tested using following standards:
- -PicoLO Nd:YAG Picosecond Laser System is tested and evaluated according to AAMI/ANSI ES60601-1:2005 and A1:2012. All the results presented in the submission demonstrate general requirements for basic safety and essential performance.
- -Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2: 2007. All the results presented here demonstrated the requirements and tests for electromagnetic disturbances.
- PicoLO Nd:YAG Picosecond Laser System is tested and evaluated according to FDA-recognized consensus standard IEC 60601-1-6:2010/AMD1:2013. All the results presented here demonstrated the General requirements for safety - Collateral Standard: Usability.
- -PicoLO Nd:YAG Picosecond Laser System is tested and evaluated according to FDArecognized consensus standard IEC 60601-2-22: 2007 (Third Edition) + A1:2012. All the results presented here demonstrated the particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- -Safety of laser products is evaluated according IEC 60825-1: 2014. All the results presented here demonstrated the equipment classification and requirements.
- -Risk management was recorded according to the FDA-recognized consensus standard ISO 14971: 2012. All the results presented here demonstrated the application of risk management to medical devices.
- -Usability was documented according to the FDA-recognized consensus standard IEC 62366: 2008. All the results presented here demonstrated the application of usability engineering to medical devices.
- -Biocompatibility was tested and evaluated according to FDA-recognized consensus standard ISO 10993-5: 2009 and ISO 10993-10: 2010.
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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
January 4, 2019
Laseroptek Co., Ltd. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, Nw Buffalo, Minnesota 55313
Re: K183392
Trade/Device Name: PicoLO Nd:YAG Picosecond 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: December 6, 2018 Received: December 7, 2018
Dear Mark Job:
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/ofdocs/ofpmn.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.
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
1
801); medical device 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183392
Device Name
PicoLO Nd:YAG Picosecond Laser System
Indications for Use (Describe)
PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064nm
The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
532nm
The 532nm wavelength of the PicoLO laser system is indicated for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
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
5. 510(k) Summary
1. General Information
| Applicant/Submitter: | Laseroptek Co., Ltd. |
|---|---|
| Address: | #116, #117, #203, #204 Hyundai I Valley 31 |
| Galmachi-Ro, 244beon-gil, Jungwon-Gu | |
| Seongnam-Si, Gyeonggido, 13212 | |
| Rep. of Korea (South Korea) | |
| Tel) +82.31.8023.5150 | |
| Fax) +82.31.8023.5151 | |
| Contact Person: | Do-Hyun Kim, BT Solutions, Inc. |
| Address: | 904, Eonju-ro 86-gil 5, |
| Gangnam-gu, Seoul, 06210, Republic of Korea | |
| Tel) +82.2.538.9140 | |
| Email) smanager@btsolutions.co.kr | |
| Preparation Date: | January-3-2019 |
2. Device Name and Code
| Device Trade Name: | PicoLO Nd:YAG Picosecond Laser System |
|---|---|
| Common Name: | Nd:YAG Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology | |
| Product Code: | GEX |
| Regulation Number: | 878.4810 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery (ODE) |
3. Predicate Device
PicoLO Nd: YAG Picosecond Laser System is substantially equivalent to the following devices
| 1 0010 J.1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Syneron Candela | PicoWay Laser System | K170597 |
| Corporation |
Table 5.1 Predicate device
4
4. Device Description
The PicoLO laser system is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm). The PicoLO Nd: YAG Picosecond Laser System consists of a set of Q-switched Nd:YAG lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.
5. Indications / Intended Use
PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064nm
The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. 532nm
The 532nm wavelength of the PicoLO laser system is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
6. Technical Characteristics in Comparison to Predicate Devices
PicoLO Nd:YAG Picosecond Laser System is substantially equivalent to the following legally marketed predicate device.
| Predicate Device | Proposed Device | |
|---|---|---|
| 510(K) Number | K170597 | N/A |
| Product Code | GEX | GEX |
| Classification / | ||
| Regulation | Class II/878.4810 | Class II/878.4810 |
| Manufacturer | Syneron Candela Corporation | Laseroptek Co.,Ltd. |
| Device Name | PicoWay Laser System | PicoLO Nd:YAG Picosecond Laser System |
| Clearance Date | 25 May 2017 | N/A |
| Intended Use / | ||
| Indications for | ||
| Use: | The PicoWay laser system is indicated for | |
| the following at the specified wavelength: | ||
| 532nm: Removal of tattoos for Fitzpatrick | ||
| skin types I-III to treat the following tattoo | ||
| colors: red, yellow and orange. |
785nm: Removal of tattoos for Fitzpatrick
skin types II-IV to treat the following tattoo
colors: green and blue. | PicoLO laser system is intended for use in
surgical and aesthetic applications in the
medical specialties of dermatology and
general and plastic surgery.
1064nm
The 1064nm wavelength of the PicoLO
laser system is indicated for tattoo removal
for all skin types (Fitzpatrick I-VI) to treat
the following tattoo colors: black, brown,
green, blue and purple. |
| | 1064nm: Removal of tattoos for all skin
types (Fitzpatrick I-VI) to treat the
following tattoo colors: black, brown,
green, blue and purple.
The PicoWay laser system is also indicated
for benign pigmented lesions removal for
Fitzpatrick Skin Types I-IV.
The Resolve handpiece (1064 nm) is also
indicated for the treatment of acne scars in
Fitzpatrick Skin Types II-V.
The Resolve handpieces are also indicated
for treatment of wrinkles in Fitzpatrick Skin
Types I-IV. | 532nm
The 532nm wavelength of the PicoLO laser
system is indicated for tattoo removal for
Fitzpatrick skin types I-III to treat the
following tattoo colors: red, yellow and
orange. |
| Wavelength | 532nm, 1064nm
785 nm | 1064/532 nm (Accuracy ±20%) |
| Pulse Duration
(Pulse Width) | 450ps (1064nm)
375ps (532nm) | 450ps (1064nm), (Accuracy ±20%)
380ps (532nm), (Accuracy ±20%) |
| Pulse Energy
(max) | 400mJ (1064nm)
200mJ (532nm) | 500mJ (1064nm), (Accuracy ±20%)
350mJ (532nm), (Accuracy ±20%) |
| Peak Power
(Gigawatts) | Up to 0.9 | 1.1 |
| Aiming Beam | Unknown | Laser diode, 635nm/