(131 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the laser technology and embedded processor for control, not AI/ML capabilities.
Yes
The device is intended for medical applications such as tattoo removal, benign pigmented lesion removal, treatment of acne scars, and wrinkles, all of which fall under the category of therapeutic interventions.
No
The device description and intended use indicate that the PicoLO laser system is used for surgical and aesthetic applications (e.g., tattoo removal, lesion removal, acne scar treatment, wrinkle treatment) rather than 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, this device is not an In Vitro Diagnostic (IVD).
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." This involves direct treatment of the patient's body (tattoo removal, lesion removal, wrinkle treatment, acne scar treatment).
- Device Description: The description details a laser system that delivers thermal energy to the skin. This is a physical intervention on the patient.
- 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) to provide information for diagnosis, monitoring, or screening.
IVDs are used to test samples outside of the body to gain information about a patient's health status. This device is used on the patient's body for treatment.
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 tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
The PicoLO laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
The PicoLO laser system 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
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 O-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
medical specialties of dermatology and general and plastic surgery. Prescription Use.
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: AAMI/ANSI ES60601-1:2005 and A1:2012, IEC 60601-1-2: 2007, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-2-22: 2007 (Third Edition) + A1:2012, IEC 60825-1: 2014, ISO -14971: 2012, IEC 62366: 2008, 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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 7, 2021
Laseroptek Co., Ltd. % Do Hyun Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul. Seoul 06210 Korea, South
Re: K203491
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: November 23, 2020 Received: November 27, 2020
Dear Do Hyun 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 U. Pandya -S
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
2
Indications for Use
510(k) Number (if known) K203491
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 tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
The PicoLO laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
The PicoLO laser system is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| For Testing Under 21 CFR 58 Subpart D | |
| For The Control Under 21 CFR 58 Subpart G |
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: | #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: | March 5, 2021 |
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
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Laseroptek Co., Ltd. | PicoLO Nd:YAG Picosecond | |
| Laser System | K183392 |
Table 5.1 Predicate device
4
Reference Device: Syneron Candela Corporation's PicoWay Laser System (K170597)
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 O-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.
The PicoLO laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
The PicoLO laser system 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 Nd: YAG Picosecond Laser System is substantially equivalent to the following legally marketed predicate device.
Table 5 2 Comparison table hetween Predicate device and Proposed device
| | TWOTE OULLYWOOD WOLF OVER POLL LAWINGS OF LAS WIN LIVE OF LOG AND LIVE
Predicate Device | Proposed Device | | |
|--|--------------------------------------------------------------------------------------------|-----------------|--|--|
| | | | | |
5
PicoLO Nd:YAG Picosecond Laser System 510(k) Summary
| 510(K) Number | K183392 | K203491 |
|---|---|---|
| Product Code | GEX | GEX |
| Classification / | ||
| Regulation | Class II/878.4810 | Class II/878.4810 |
| Manufacturer | Laseroptek Co.,Ltd. | Laseroptek Co.,Ltd. |
| Device Name | PicoLO Nd:YAG Picosecond Laser System | PicoLO Nd:YAG Picosecond Laser System |
| Clearance Date | 11 Feb 2019 | 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 tattoo removal for
Fitzpatrick skin types I-III to treat the
following tattoo colors: red, yellow and
orange. | 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.
The PicoLO laser system is also indicated
for benign pigmented lesions removal for
Fitzpatrick Skin Types I-IV.
The 1064 handpiece (1064nm) is also
indicated for the treatment of acne scars in
Fitzpatrick Skin Types II-V.
The PicoLO laser system is also indicated
for treatment of wrinkles in Fitzpatrick Skin
Types I-IV. |
| Wavelength | 1064/532 nm (Accuracy ±20%) | 1064/532 nm (Accuracy ±20%) |
| Pulse Duration
(Pulse Width) | 450ps (1064nm), (Accuracy ±20%)
380ps (532nm), (Accuracy ±20%) | 450ps (1064nm), (Accuracy ±20%)
380ps (532nm), (Accuracy ±20%) |
| Pulse Energy
(max) | 500mJ (1064nm), (Accuracy ±20%)
350mJ (532nm), (Accuracy ±20%) | Tattoo Mode
500mJ (1064nm), (Accuracy ±20%)
350mJ (532nm), (Accuracy ±20%)
PH Mode*
400mJ (1064nm), (Accuracy ±20%) |
| | | 200mJ (532nm), (Accuracy ±20%) |
| Peak Power
(Gigawatts) | 1.1 | 1.1 |
| Aiming Beam | Laser diode, 635nm/ |
| | | 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. |
| | green, blue and purple. | 532nm |
| | The PicoWay laser system is also indicated
for benign pigmented lesions removal for
Fitzpatrick Skin Types I-IV. | 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 |
| | The Resolve handpiece (1064 nm) is also
indicated for the treatment of acne scars in
Fitzpatrick Skin Types II-V. | orange. |
| | The Resolve handpieces are also indicated | |
| | for treatment of wrinkles in Fitzpatrick Skin
Types I-IV. | The PicoLO laser system is also indicated
for benign pigmented lesions removal for
Fitzpatrick Skin Types I-IV. |
| | | The 1064 handpiece (1064nm) is also
indicated for the treatment of acne scars in
Fitzpatrick Skin Types II-V. |
| | | The PicoLO laser system is also indicated
for treatment of wrinkles in Fitzpatrick Skin
Types I-IV. |
| 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/