(114 days)
Not Found
No
The document describes a laser system controlled by an embedded processor, but there is no mention of AI, ML, image processing, or any related concepts in the device description, intended use, or performance studies.
Yes
The device is intended for clinical applications like tattoo removal, benign pigmented lesion removal, treatment of acne scars, and treatment of wrinkles, which are therapeutic interventions.
No
Explanation: The device description and intended use of the PicoLO Premium indicate it is a multi-wavelength pulsed laser system for treatment purposes (tattoo removal, benign pigmented lesion removal, acne scar treatment, wrinkle treatment), not for diagnosing conditions.
No
The device description explicitly states it is a "multi-wavelength, pulsed laser system" consisting of hardware components like a main body, color touch screen, articulated arm, hand piece, and foot switch. It is not solely software.
Based on the provided information, the PicoLO Premium is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "surgical and aesthetic applications" and is used for "tattoo removal," "benign pigmented lesions removal," "treatment of acne scars," and "treatment of wrinkles." These are all procedures performed directly on the patient's body.
- Device Description: The description details a "multi-wavelength, pulsed laser system" that uses "focusing optics to deliver a pattern of thermal energy to the epidermis and dermis." This describes a device that interacts physically with the patient's tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) outside of the body. IVDs are designed to perform tests on these types of samples to provide information for diagnosis, monitoring, or screening.
Therefore, the PicoLO Premium is a therapeutic and aesthetic laser device, not an IVD.
N/A
Intended Use / Indications for Use
PicoLO Premium 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 Premium 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 532mm wavelength of the PicoLO Premium is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
The PicoLO Premium is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The DIA FX 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. PicoLO Premium is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
PicoLO Premium 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 Premium 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
Skin (epidermis and dermis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical specialties of dermatology and general and plastic surgery.
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 Premium 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 Premium 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: 2014. All the results presented here demonstrated the requirements and tests for electromagnetic disturbances.
- -PicoLO Premium 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 Premium is tested and evaluated according to FDA-recognized 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.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 8, 2021
Laseroptek Co., Ltd. % Do Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul, Seoul 06210 Korea. South
Re: K212573
Trade/Device Name: PicoLO Premium 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: August 13, 2021 Received: August 16, 2021
Dear Do Kim:
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/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
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 803) for devices or postmarketing safety reporting (21 CFR 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 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 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.
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212573
Device Name PicoLO Premium
Indications for Use (Describe)
PicoLO Premium 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 Premium 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 532mm wavelength of the PicoLO Premium is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
The PicoLO Premium is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The DIA FX 1064 handpiece (1064mm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. PicoLO Premium is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
Type of Use (Select one or both, as applicable)
| Research Use (21 CFR 201.3 Subject to Change) |
|---|
| In Vitro Diagnostic Use (21 CFR 809.3 Subject to Change) |
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: | #114, #116, #117, #203, #204 Hyundai I Valley 31 |
| Galmachi-Ro, 244beon-gil, Jungwon-Gu | |
| Seongnam-Si, Gyeonggi-do, 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) ceo@btsolutions.co.kr | |
| Preparation Date: | November 4, 2021 |
2. Device Name and Code
| Device Trade Name: | PicoLO Premium |
|---|---|
| Common Name: | Nd:YAG Laser System |
| 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 Premium is substantially equivalent to the following devices
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Laseroptek Co., Ltd. | PicoLO Nd:YAG Picosecond | |
| Laser System | K203491 |
Table 5.1 Predicate device
4
4. Device Description
PicoLO Premium 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 Premium 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 Premium 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 Premium 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 Premium is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
The PicoLO Premium is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The DIA FX 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
PicoLO Premium is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
6. Technical Characteristics in Comparison
6.1. Technical Characteristics in Comparison to Predicate Device
PicoLO Premium is substantially equivalent to the following legally marketed predicate device.
| Proposed Device | Proposed Device | |
|---|---|---|
| 510(K) Number | K203491 | |
| Product Code | GEX | GEX |
| Classification / | ||
| Regulation | Class II/878.4810 | Class II/878.4810 |
| Manufacturer | Laseroptek Co.,Ltd. | Laseroptek Co.,Ltd. |
Table 5.2 Comparison table between Predicate device and Proposed device
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PicoLO Premium 510(k) Summary
| Device Name | PicoLO Nd:YAG Picosecond
Laser System | PicoLO Premium | Pulse Duration
(Pulse Width) | 450ps (1064nm), (Accuracy ±20%)
380ps (532nm), (Accuracy ±20%) | 450ps (1064nm), (Accuracy ±20%)
380ps (532nm), (Accuracy ±20%) |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Clearance Date | April 7, 2021 | N/A | Pulse Energy
(max) | Tattoo Mode
500mJ (1064nm), (Accuracy
±20%)
350mJ (532nm), (Accuracy ±20%) | Tattoo Mode
500mJ (1064nm), (Accuracy
±20%)
350mJ (532nm), (Accuracy ±20%) |
| 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. | PicoLO Premium is intended for
use in surgical and aesthetic
applications in the medical
specialties of dermatology and
general and plastic surgery. | | PH Mode* | PH Mode* |
| | | | | 400mJ (1064nm), (Accuracy
±20%)
200mJ (532nm), (Accuracy ±20%) | 400mJ (1064nm), (Accuracy
±20%)
200mJ (532nm), (Accuracy ±20%) |
| | 1064nm | 1064nm | Peak Power
(Gigawatts) | 1.1 | 1.1 |
| | 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. | The 1064nm wavelength of the
PicoLO Premium is indicated for
tattoo removal for all skin types
(Fitzpatrick I-VI) to treat the
following tattoo colors: black,
brown, green, blue and purple. | Aiming Beam | Laser diode, 635nm/ | | Laser Type | Q-switched Nd:YAG Laser | Q-switched Nd:YAG Laser |
| | The PicoLO laser system is also
indicated for benign pigmented
lesions removal for Fitzpatrick
Skin Types I-IV. | The PicoLO Premium is also
indicated for benign pigmented
lesions removal for Fitzpatrick
Skin Types I-IV. | Activation | Via foot-switch | Via foot-switch |
| | The 1064 handpiece (1064nm) is
also indicated for the treatment of
acne scars in Fitzpatrick Skin
Types II-V. | The DIA FX 1064 handpiece
(1064nm) is also indicated for the
treatment of acne scars in
Fitzpatrick Skin Types II-V. | Display | TFT LCD Touch screen | TFT LCD Touch screen |
| | The PicoLO laser system is also
indicated for treatment of wrinkles
in Fitzpatrick Skin Types I-IV. | PicoLO Premium is also indicated
for treatment of wrinkles in
Fitzpatrick Skin Types I-IV. | Cooling System | Internal water to air heat exchanger | Internal water to air heat exchanger |
| Wavelength | 1064/532 nm (Accuracy ±20%) | 1064/532 nm (Accuracy ±20%) | Electrical Power | 220-230VAC, 50/60Hz | 220-230VAC, 50/60Hz |
| Beam Delivery
System | Articulated Arm with Handpiece | Articulated Arm with Handpiece | | | |
| System
Dimensions(mm) | 350(W) x 1080(L) x 970(H) | 350(W) x 1080(L) x 970(H) | | | |
| System Weight
(kg) | 110 kg | 110 kg | | | |
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PicoLO Premium
510(k) Summary
PH mode* is intended for 3 newly added indications, as below;
-
- benign pigmented lesions removal for Fitzpatrick Skin Types I-IV,
- the treatment of acne scars in Fitzpatrick Skin Types II-V, and 2)
-
- the treatment of wrinkles in Fitzpatrick Skin Types I-IV.
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PicoLO Premium 510(k) Summary
7. Performance Data
Non-clinical tests: Testing conducted on the PicoLO Premium 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 Premium 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: 2014. All the results presented here demonstrated the requirements and tests for electromagnetic disturbances.
- -PicoLO Premium 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 Premium is tested and evaluated according to FDA-recognized 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.
8. Substantial Equivalence
The PicoLO Premium, subject of this submission, is modifications of the PicoLO Nd:YAG Picosecond Laser System cleared under K203491.
The modifications are:
- (1) changing the names of three handpieces, and
- (2) adding new two handpieces.
These modifications do not affect technological principles between the modified device and the predicate device.
Based upon the predicted overall performance characteristics for the PicoLO Premium, Laseroptek Co. Ltd. believes that no significant differences exist in usage of its underlying technological principles between PicoLO Premium and the predicate device.
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9. Conclusions
The technological characteristics of the subject device PicoLO Premium are comparable to the predicate device for comparable indications for use. Thus, subject device PicoLO Premium is concluded to be substantially equivalent to the predicate.