· 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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the PICOHI laser device. It does not present any clinical study data or acceptance criteria for AI/ML performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (PICOWAY) primarily through non-clinical testing and a comparison of technological characteristics.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets those criteria, specifically regarding AI/ML performance, because the document explicitly states:

"8. Clinical tests submitted - 807.92(b)(2) No clinical performance testing was performed." (Page 7)

And the entire document is about a laser surgical instrument, not an AI/ML device.

To address your prompt based on the provided document:

The acceptance criteria and study proving the device meets them, as presented in this 510(k) submission, are centered on non-clinical performance and a comparison to a predicate device, not on AI/ML.

Here's a breakdown of what the document does provide regarding the device's acceptance (which is substantial equivalence through non-clinical means):

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

The acceptance criteria are implied by the standards and characteristics the device must meet to be deemed substantially equivalent to the predicate. The "reported device performance" is essentially that the device passed these non-clinical tests and exhibits comparable technological characteristics.

Acceptance Criteria (Implied by Standards/Comparison)	Reported Device Performance
Basic Safety & Essential Performance: Compliance with IEC 60601-1:2012	Evaluated in accordance with IEC 60601-1:2012.
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2014	Evaluated in accordance with IEC 60601-1-2:2014.
Laser Product Safety: Compliance with IEC 60825-1:2014	Evaluated in accordance with IEC 60825-1:2014.
Usability: Compliance with IEC 60601-1-6:2013 and IEC 62366:2007	Evaluated in accordance with IEC 60601-1-6:2013 and IEC 62366:2007.
Low Intensity Laser System Basic Safety & Essential Performance: Compliance with IEC 60601-2-22:2012	Evaluated in accordance with IEC 60601-2-22:2012.
Risk Management: Compliance with ISO 14971:2007 (implied as risk management is "recorded")	Recorded in the reference of ISO 14971:2007.
Software Verification & Validation: Compliance with IEC 62304:2006 (moderate level of concern)	Verified and validated in accordance with its moderate level of concern. Evaluated according to IEC 62304:2006.
Technological Characteristics Comparability to Predicate (PICOWAY K191685):	- Laser Source: Nd:YAG (Same)- Wavelength: 532/1064 nm (Same)- Max. Fluence: 16.00 J/cm² (PICOHI) vs. 12.5 J/cm² (PICOWAY) - Different, but deemed acceptable for substantial equivalence.- Pulse Width: 275-300 ps (PICOHI) vs. 375-450 ps (PICOWAY) - Different, but deemed acceptable for substantial equivalence.- Max. Repetition: 10 Hz (Same)- Spot Size: 1.5-13 mm (PICOHI) vs. 2-10 mm (PICOWAY) - Different, but deemed acceptable for substantial equivalence.- Rated Input: 220-240 VAC, 50/60 Hz, 20 A (PICOHI) vs. 200-240 VAC, 50/60 Hz, 30 A (PICOWAY) - Different, but deemed acceptable for substantial equivalence.
Intended Use & Indications for Use: Same as/similar to predicate.	Same intended use; similar indications for use, with PICOHI having a slightly narrower range of indications (e.g., no 730/785nm wavelengths, no acne scar or wrinkle treatment indications as listed for predicate).

2. Sample Size for Test Set and Data Provenance:

Sample Size: Not applicable in the traditional sense of a clinical trial or AI/ML test set. The "test set" for this device's acceptance consists of the device itself undergoing various laboratory and engineering tests (bench testing, electrical safety, EMC, software V&V, etc.). No patient samples were used for performance evaluation for this 510(k).
Data Provenance: Not applicable as no clinical or patient data was used for performance testing. The "data" comes from the results of the non-clinical engineering and safety tests conducted on the device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Experts: Not applicable. Ground truth, in the context of an AI/ML device, is established by human experts or definitive diagnostic tests. For this laser device, the "ground truth" for its safety and performance is established by its adherence to recognized engineering standards and a comparison of its physical and operational characteristics to a legally marketed predicate device.
Qualifications: Not specified, as it's not a human-data-driven evaluation. The experts performing the non-clinical tests would be engineers, physicists, and quality assurance personnel with expertise in medical device safety and performance testing.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. There's no human interpretation or disagreement on results to adjudicate in the context of the non-clinical tests described. The results are quantitative measurements against defined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No, there was no MRMC comparative effectiveness study, as this is not an AI/ML device, and no clinical data was submitted for performance evaluation.

6. Standalone (Algorithm Only Without Human-in-the Loop) Performance:

Standalone Performance: Not applicable. This is a physical laser device, not an AI/ML algorithm.

7. Type of Ground Truth Used:

Ground Truth: For this type of device and submission, the "ground truth" for acceptance is successful completion of non-clinical engineering and safety standards (e.g., IEC standards) and a demonstration of substantial equivalence in technological characteristics and intended use to a predicate device.

8. Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This device does not use an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth Establishment for Training Set: Not applicable, as there is no AI/ML training set.

Summary

{0}------------------------------------------------

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.

{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 Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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

K201773

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 adesign-related recall.
-----------------------------	-------------------------------------------------------------------------------------------------

{4}------------------------------------------------

4. Device Description - 807.92(a)(4)

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.

{5}------------------------------------------------

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
ClassificationName	Powered laser surgical instrument	Powered laser surgical instrument
Indication for use	The PICOHI is indicated for the followingat the specified wavelength:• 532 nm: Removal of tattoos forFitzpatrick skin types I-III to treat thefollowing tattoo colors: red, yellow andorange.• 1064 nm: Removal of tattoos for all skintypes (Fitzpatrick I-VI) to treat thefollowing tattoo colors: black, brown,green, blue and purple.• Treatment of benign pigmented lesionsfor Fitzpatrick skin types I-IV.	The PicoWay laser system is indicatedfor the following at the specifiedwavelength:• 532 nm: Removal of tattoos forFitzpatrick skin types I-III to treat thefollowing tattoo colors: red, yellow andorange.• 730 nm: Removal of tattoos forFitzpatrick skin types II-IV to treat thefollowing tattoo colors: green and blue.• 785 nm: Removal of tattoos forFitzpatrick skin types II-IV to treat thefollowing tattoo colors: green and blue.• 1064 nm: Removal of tattoos for all skintypes (Fitzpatrick I-VI) to treat thefollowing tattoo colors: black, brown,green, blue and purple.• The Picoway laser system is alsoindicated for benign pigmented lesionsremoval for Fitzpatrick Skin Types I-IV.• The Resolve handpiece (1064 nm) isalso indicated for the treatment of acnescars in Fitzpatrick Skin Types II-V.• The Resolve handpieces (532 nm HE,532 nm, 1064 nm) are also indicated fortreatment of wrinkles in Fitzpatrick SkinTypes I-IV• The Resolve Fusion handpiece (1064nm) 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

{6}------------------------------------------------

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.

{7}------------------------------------------------

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.

{8}------------------------------------------------

Best Regard,

September 10, 2021

Regulatory Affair Manager, R&D Dept.

Regulation Number and Section

§ 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.