(477 days)
Not Found
No
The provided text describes a laser system for tattoo and lesion removal, focusing on its technical specifications (wavelengths, pulse duration, delivery system). There is no mention of AI, ML, image processing, or any data-driven algorithms that would suggest the use of AI/ML technology.
Yes.
The device is used for the removal of tattoos and the treatment of benign pigmented lesions, which are therapeutic interventions.
No
The device is described as a laser system for the removal of tattoos and benign pigmented lesions, which are therapeutic applications, not diagnostic ones.
No
The device description clearly states it is a solid-state laser system with hardware components like a laser head, articulated arm, and handpiece, which are not software-only elements.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- PICOHI Function: The PICOHI is a laser system that directly interacts with the human body (skin) to perform procedures (tattoo removal, treatment of pigmented lesions). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes therapeutic procedures performed on the patient, not diagnostic tests performed on samples.
Therefore, the PICOHI falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PICOHI is indicated for the following at the specified wavelength:
- · 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
- · 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The PICOHI is a solid-state laser capable of delivering energy at wavelengths of 1064nm, 532nm at extremely short duration in the range of 275-300ps. The laser system contains one 1064nm (Nd:YAG) laser head which is used to create the 1064nm picosecond wavelength which can be frequency-doubled to 532nm as desired. The outputs of the two lasers are designed to be colinear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 1064nm or 532nm wavelengths. All these energies are delivered through an articulated arm and corresponding handpiece.
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
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 were submitted, including evaluation of basic safety and essential performance (IEC 60601-1:2012), electromagnetic disturbances (IEC 60601-1-2:2014), laser product safety (IEC 60825-1:2014), usability (IEC 60601-1-6:2013, IEC 62366:2007), low intensity laser system requirements (IEC 60601-2-22:2012), risk management (ISO 14971:2007), and software verification and validation (IEC 62304:2006). No clinical performance testing was performed. The non-clinical data, including biocompatibility, bench testing, hardware, and software documentation, demonstrate that the device performs as intended and is safe to use, meeting required standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
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§ 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 the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 19, 2021
Hironic Co., Ltd. Seo Ji Yeong Regulatory Affairs 19F,767, Sinsu-Ro, Suji-Gu Yongin-Si, Gyeonggi-do 16827 Korea, Republic Of
Re: K201773
Trade/Device Name: PICOHI 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 15, 2021 Received: September 15, 2021
Dear Seo Ji Yeong:
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.
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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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201773
Device Name PICOHI
Indications for Use (Describe)
The PICOHI is indicated for the following at the specified wavelength:
- · 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
- · 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
- · Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "HIRONIC" in black letters with a red square to the left of the word. The font is sans-serif and the letters are bold. The red square is a stylized version of the letter "H".
510(k) Summary
This summary of 510(k) Safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter Information – 807.92(a)(1)
| Applicant | Hironic Co., Ltd. |
|---|---|
| Address | 19F, 767, Sinsu-ro, Suji-gu, Yongin-si, Gyeonggi-do, |
| 16827, Republic of Korea | |
| Phone Number | +82-31-525-7000 |
| Fax Number | +82-31-525-7010 |
| Contact Person | Jiyeon, Woo |
| Contact Information | m. +82-10-8725-4345 |
| e. ra@hironic.com | |
| Preparation Date | 2021/09/10 |
2. Device Name and Code - 807.92(a)(2)
| Device Trade Name | PICOHI |
|---|---|
| Common Name | Laser Surgical Instrument |
| Classification Name | Powered Laser Surgical Instrument |
| Product Code | GEX |
| Regulation Number | 21 CFR § 878.4810 |
| Regulatory Class | Class II |
| Review Panel | General & Plastic Surgery |
3. Legally marketed device(s) to which equivalence is claimed - 807.92(a)(3)
| Predicate Devices for laser | PICOWAY(K191685)
This predicate devices have not been subject to a
design-related recall. |
| ----------------------------- | ------------------------------------------------------------------------------------------------- |
|---|
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4. Device Description - 807.92(a)(4)
The PICOHI is a solid-state laser capable of delivering energy at wavelengths of 1064nm, 532nm at extremely short duration in the range of 275-300ps. The laser system contains one 1064nm (Nd:YAG) laser head which is used to create the 1064nm picosecond wavelength which can be frequency-doubled to 532nm as desired. The outputs of the two lasers are designed to be colinear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 1064nm or 532nm wavelengths. All these energies are delivered through an articulated arm and corresponding handpiece.
5. Indication for Use - 807.92(a)(5)
The PICOHI is indicated for the following at the specified wavelength:
- 532 nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
- 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
The PICOHI is also indicated for treatment of benign pigmented lesions for Fitzpatrick Skin Types I-IV.
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6. Summary of the Technological Characteristics of the Device Compared to the Predicate - 807.92(a)(6)
(1) Predicate device
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K201773 | K191685 |
| Manufacturer | Hironic Co., Ltd. | Candela Corporation |
| Device Name | PICOHI | PICOWAY |
| Classification | ||
| Name | Powered laser surgical instrument | Powered laser surgical instrument |
| Indication for use | The PICOHI is indicated for the following | |
| at the specified wavelength: | ||
| • 532 nm: Removal of tattoos for | ||
| Fitzpatrick skin types I-III to treat the | ||
| following tattoo colors: red, yellow and | ||
| orange. | ||
| • 1064 nm: Removal of tattoos for all skin | ||
| types (Fitzpatrick I-VI) to treat the | ||
| following tattoo colors: black, brown, | ||
| green, blue and purple. | ||
| • Treatment of benign pigmented lesions | ||
| for Fitzpatrick skin types I-IV. | The PicoWay laser system is indicated | |
| for the following at the specified | ||
| wavelength: | ||
| • 532 nm: Removal of tattoos for | ||
| Fitzpatrick skin types I-III to treat the | ||
| following tattoo colors: red, yellow and | ||
| orange. | ||
| • 730 nm: Removal of tattoos for | ||
| Fitzpatrick skin types II-IV to treat the | ||
| following tattoo colors: green and blue. | ||
| • 785 nm: Removal of tattoos for | ||
| Fitzpatrick skin types II-IV to treat the | ||
| following tattoo colors: green and blue. | ||
| • 1064 nm: 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 (532 nm HE, | ||
| 532 nm, 1064 nm) are also indicated for | ||
| treatment of wrinkles in Fitzpatrick Skin | ||
| Types I-IV | ||
| • The Resolve Fusion handpiece (1064 | ||
| nm) is indicated for the treatment of | ||
| wrinkles as well as benign pigmented | ||
| lesions in Fitzpatrick Skin Types I-IV | ||
| • The Resolve Fusion handpiece (532 | ||
| nm) is indicated for the treatment of | ||
| benign pigmented lesions in Fitzpatrick | ||
| Skin Types I-IV | ||
| Laser Source | Nd:YAG | Nd:YAG |
| Wavelength | 532/1064 nm | 532/1064 nm |
| Max. Fluence | 16.00 J/cm² | 12.5 J/cm² |
| Pulse Width | 275-300 ps | 375-450 ps |
| Max. Repetition | 10 Hz | 10 Hz |
| Spot Size | 1.5-13 mm | 2-10 mm |
| • Zoom (532 nm): 1.5-7.5 mm | ||
| • Zoom (1064 nm): 10 mm | ||
| • Collimated (1064 nm): 10 mm | ||
| • VMLA (532/1064 nm): 13 mm | ||
| • ZMLA (532/1064 nm): 12 mm | ||
| • DOE (532/1064 nm): 10 mm | ||
| Rated Input | 220-240 VAC, 50/60 Hz, 20 A | 200-240 VAC, 50/60 Hz, 30 A |
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7. Non-clinical tests submitted - 807.92(b)(1)
- Basic safety and essential performance of the PICOHI is evaluated in accordance with IEC 60601-1:2012.
- Effect to the device by electromagnetic disturbances is evaluated in accordance with the FDArecognized consensus standard, IEC 60601-1-2:2014.
- Safety of laser products are evaluated in accordance with IEC 60825-1:2014.
- General Requirements for Basic Safety and Essential Performance Collateral Standard: Usability is evaluated in accordance with the FDA-recognized consensus standard, IEC 60601-1-6:2013.
- Particular Requirements for Basic Safety and Essential Performance of Low Intensity Laser System are evaluated in accordance with IEC 60601-2-22:2012.
- Risk management is recorded in the reference of ISO 14971:2007.
- The software for PICOHI is verified and validated in accordance with its moderate level of concern. Software life cycle processes are evaluated according to the FDA-recognized consensus standard, IEC 62304:2006.
- Application of usability engineering to medical devices is evaluated in accordance with IEC 62366:2007.
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8. Clinical tests submitted - 807.92(b)(2)
No clinical performance testing was performed.
9. Conclusions drawn from clinical and non-clinical tests submitted
The PICOHI and the predicate devices have the same intended use with similar indications for use. The PICOHI Laser System presents the same or similar technological characteristics as its predicate devices, including the laser type, wavelengths, device design, pulse width, frequency, spot sizes and system components. PICOHI is substantially equivalent to its predicate devices with same indication for use and technological characteristics. The non-clinical data for proposed device, including biocompatibility, bench testing, hardware, and software documentation shows that the device should perform as intended in the specified use. In addition, the Electromagnetic Compatibility and Electrical Safety testing shows that the device is safe to use and meets required standards. These non-clinical tests show that the PICOHI can safely deliver laser energies to the patient as intended. The device meets design specifications as well as performance requirements. Any minor differences do not present any new types of safety or effectiveness questions since the PICOHI parameters are similar to or within the range of the predicates. Further, PICOHI performance has been demonstrated in non-clinical investigations, and results confirm the safety and performance of the device. The PICOHI device and its predicates all operate with the same mechanism of action based on selective photothermolysis of pigment particles using laser energy. Therefore, the PICOHI has the same intended use and similar indications for use, technological characteristics, and principles of operation as the predicate devices. The PICOHI is substantially equivalent to the predicate devices.
10. Summary of Substantial Equivalence
PICOHI is substantially equivalent to its predicate devices with same indication for use and technological characteristics. The non-clinical data for proposed device, including biocompatibility, bench testing, hardware, and software documentation shows that the device should perform as intended in the specified use. In addition, the Electromagnetic Compatibility and Electrical Safety testing shows that the device is safe to use and meets required standards. These non-clinical tests show that the PICOHI can safely deliver laser energies to the patient as intended. The device meets design specifications as well as performance requirements.
Any minor differences in the human interface and accessories design do not raise any new types of safety and effectiveness issues, as verified by performance testing.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification that we conclude that substantially equivalent with predicate device.
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Best Regard,
September 10, 2021
S
Regulatory Affair Manager, R&D Dept.