IRIS Pi Q switched Nd YAG laser system is indicated for the Incision, Excision, Ablation Vaporization of soft tissues for general dermatologic and general surgery procedures for Coagulation and Hemostasis

532nm wavelength

Tattoo removal light ink (red, tan, purple, orange, sky blue) Removal of benign epidermal pigmented lesions, Minor benign vascular lesions, Talangietasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi, Freckles. Treatment of Post inflammatory Hyperpigmentation ( PIH)

1064nm wavelength

Tattoo removal dark ink (black, blue, green) Removal of Nevus of Ota, Removal or lightening of unwanted hair, Treatment of Common Nevi, Melasma Skin resurfacing procedures for treatment of Acne Scars, Wrinkle

Device Description

The IRIS Pi O-Switched Nd:YAG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and using two non-fractional handpieces (Zoom handpiece and 7mm collimated handpiece) is able to control various treatment fluence.

laser tube : placed in the mixed crystals of copper pipe to the heater and produces a laser beam, Resonator : amplifies the beam, through the Xe-gas contained lamp : Xe-gas contains high pressure lamp to increase specific laser beam lamp

This converted light energy creates the Nd: Y AG crystal and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the tissue by means of an articulated arm and a specially designed adjustable spot size Hand Piece.

The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.

This system also consist of

Optic main Bench assembly, Articulated Arm Hand pieces, LCD control panel, Cooling system, Foot Pedal Switch

AI/ML Overview

This document is a 510(k) summary for the IRIS Pi Q-switched Nd:YAG laser, comparing it to a predicate device (K171648 BM.IRIS Nd:YAG). It does not describe acceptance criteria or a study proving the device meets said criteria in the way typically expected for an AI/CADe device. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through technical specifications and adherence to general safety and performance standards for laser medical devices.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to this type of submission, as it's not for a diagnostic AI/CADe device.

Here's an analysis based on the provided text, addressing the applicable points and explicitly stating when information is not present:

Summary of Acceptance Criteria and Device Performance (Not Applicable - Device is a laser, not AI/CADe)

This submission does not provide acceptance criteria in the typical sense for an AI/CADe or diagnostic device, nor does it report specific device performance metrics against such criteria. The device is a laser system, and its "performance" is assessed by comparing its technical specifications to those of a predicate device and by demonstrating adherence to international safety standards for laser products.

1. A table of acceptance criteria and the reported device performance

As this is a laser surgical instrument, the "acceptance criteria" are primarily related to safety and efficacy as demonstrated through substantial equivalence to a predicate device and compliance with relevant international standards. There are no specific performance metrics like sensitivity, specificity, or AUC mentioned in the context of diagnostic decision-making that would be typically found for an AI/CADe device.

Here's a table based on the comparison to the predicate device, highlighting differences that were reviewed for safety and effectiveness:

Characteristic	Acceptance Criteria (Predicate Device K171648)	Reported Device Performance (K221789 IRIS Pi)	Comment
Laser Type	Nd YAG	Nd YAG	Same
Wavelength	1064/532 nm	1064/532 nm	Same
Operating Mode	Q-switched	Q-switched	Same
Mode Names	1064, 532, SLP, BLUE Toning	1064, 532, SLP, BLUE T	Same
Max Pulse Energy (mJ)	1200 @ 1064 nm (Q)	1600 @ 1064 nm (Q)	Different
	400 @ 532 nm (Q)	500 @ 532 nm (Q)	Different
	1500 @ 1064 nm (SLP)	2000 @ 1064 nm (SLP)	Different
	1000 @ 1064 nm (Blue Toning, PTP)	1500 @ 1064 nm (BLUE T)	Different
Spot Size (mm)	2-10 @ 1064 nm	2-10 @ 1064 nm	Same
	1.5-8 @ 532 nm	2-10 @ 532 nm	Comparable
Pulse Duration (ns)	5-10 nm (all modes)	5-10 nm (all modes)	Same
Repetition Rate (Hz)	10-20 @ 1064/532 nm (Q)	1-10 @ 1064/532 nm (Q)	Different
	10-20 @ 1064 nm (SLP)	1-10 @ 1064 nm (SLP)	Different
	10-20 @ 1064 nm (Blue Toning, PTP)	1-15 @ 1064 nm (BLUE T)	Different
Aiming Beam	<3 mW @ 655 nm	<3 mW @ 655 nm	Same
Cooling System	Water cooling	Water cooling	Same
Dimensions	295 x 740 x 1680 mm	270 x 700 x 750 mm	Comparable
Weight	70 kg	90 kg	Comparable

Conclusion stated in the document: The differences in Maximum Pulse Energy and Repetition Rate "are not expected to significantly alter the safety and effectiveness of the subject device compared to the predicate device" because "the maximum repetition rate for the subject device is lower than that of the predicate device, the energy delivered by the subject device is lower than or comparable to the predicate device."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This submission is for a laser surgical instrument, not an AI/CADe device that relies on a "test set" of medical images or patient data to evaluate algorithmic performance. The evaluation is based on technical specifications and adherence to performance standards.
The document states: "Clinical data is not required in this submission".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As no clinical data or "test set" was used to evaluate a diagnostic or AI algorithm, there was no need for experts to establish ground truth in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or human adjudication was performed for this laser device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI/CADe device, and therefore no MRMC study or evaluation of human reader improvement with AI assistance was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical laser device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. As no diagnostic claims or AI/CADe functionality are involved, "ground truth" in the traditional sense of medical image analysis is not established for this device. The 'truth' in this context is adherence to fundamental engineering and safety standards for laser devices.

8. The sample size for the training set

Not Applicable. This is a hardware device, not an AI model, and therefore does not have a "training set."

9. How the ground truth for the training set was established

Not Applicable. No training set was used.

Performance Tests Conducted (from section 8 of the 510(k) Summary):

The device's performance and safety were demonstrated by compliance with the following mandatory and voluntary standards:

AAMI/ANSI ES60601-1:2005® 2012 And A1:2012: General requirement for basic safety and essential performance.
IEC60601-1-2: 2014: Electro Magnetic Compatibility test.
IEC60601-2-22: Part 2, Particular requirements for safety of diagnostic and Therapeutic laser.
IEC60825-1: 2nd ED: Equipment classification and requirement.
IEC60601-2 Part 6: General requirements for safety - Collateral Standard: Usability.
Software Verification and Validation test: Conducted and documentation provided as recommended by FDA guidance and IEC62304. Results found acceptable for software release.
Biocompatibility: The device uses non-contact mode, and the handpiece tips are made of SS.304, same as the predicate device.

These tests serve as the "study" proving the device's acceptable performance in terms of safety and adherence to recognized standards for laser medical devices, supporting its substantial equivalence claim.

Summary

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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.

August 9, 2022

Bio-Med USA Inc Young Chi CEO 27 New England Dr Ramsey, New Jersey 07446

Re: K221789

Trade/Device Name: IRIS Pi Q switched Nd YAG laser 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: June 16, 2022 Received: June 21, 2022

Dear Young Chi:

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.

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

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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 and Part 809); 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,

Jianting Wang Acting 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) K221789

Device Name

IRIS Pi Q switched Nd YAG laser

Indications for Use (Describe)

532nm wavelength

1064nm wavelength

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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510 (K) Summary

As required by CFR 807.92(c)

(Reg3014144061)

1. Manufacturer.

Prepared July 25, 2022

BlueCore company Co., Ltd. Acehigh 21, 48 Centum-Jungang ro 12 Haeundae Gu, Busan, Rep of Korea T: 82 51 747 4318, F: 82 51 747 4319

2. Submitter

Bio-Med USA Inc. Young Chi, CEO. 27 New England Drive, Ramsey, NJ 07446. U.S.A. t: 1 973 278 5222 f: 1 201 934 6030 e mail: biomedusa(@msn.com

3. Name of Device

Trade name	: IRIS Pi Q switched Nd:YAG laser
Classification name	: Laser surgical instrument for use in generaland plastic surgery and in dermatology
Common name	: Powered, Laser Surgical instrument
Regulation	: 878.4810 Class II
Product Code	: GEX
Type of submission	: Traditional

4. Legally marketed Predicate Device

K171648 BM.IRIS Nd:YAG Bluecore Company Co Ltd

5. Device Description

K221789

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K221789

This system also consist of

Optic main Bench assembly, Articulated Arm Hand pieces, LCD control panel, Cooling system, Foot Pedal Switch

6. Indication for use

IRIS Pi Q-switched Nd : YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength

Tattoo removal light ink (red, tan, purple, orange, sky blue,) Removal of Benign Epidermal Pigmented Lesions, Minor Benign Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi, Freckles Treatment of Post inflammatory Hyperpigmentation (PIH)

1064nm Wavelength:

Tattoo removal: dark ink (black, blue, green ) Removal of Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi, Melasma, Skin resurfacing procedures for the treatment of acne scars, wrinkle

7 Comparison to Predicate Device

Device & PredicateDevice(s):	K221789	K171648	Comment
General Device Characteristics
Laser Type	Nd YAG	Nd YAG	Same
Wavelength	1064/532 nm	1064/532 nm	Same
Operating Mode	Q-switched	Q-switched	Same
Mode Names	1064, 532, SLP, BLUE T	1064, 532, SLP, BLUE Toning	Same
Maximum Pulse Energy(mJ)	1600 @ 1064 nm (Q)500 @ 532 nm (Q)2000 @ 1064 nm (SLP)1500 @ 1064 nm (BLUE T)	1200 @ 1064 nm (Q)400 @ 532 nm (Q)1500 @ 1064 nm (SLP)1000 @ 1064 nm (Blue Toning, PTP)	Different
Spot Size (mm)	2-10 @ 1064 nm2-10 @ 532 nm	2-10 @ 1064 nm1.5-8 @ 532 nm	Comparable

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		K221789
Pulse Duration (ns)	5-10 @1064 nm (Q)	5-10 @1064 nm (Q)	Same
	5-10 @ 532 nm (Q)	5-10 @ 532 nm (Q)
	5-10 @ 1064 nm (SLP)	5-10 @ 1064 nm (SLP, Non Q)
	5-10 @ 1064 nm (BLUE T)	5-10 @ 1064 nm (Blue Toning, PTP)
Repetition Rate (Hz) @ spot size	1-10 @ 2-10mm @1064nm (Q)	10-20 @ 2-10mm @1064nm (Q)	Different
	1-10 @ 2-10mm @ 532nm (Q)	10-20 @ 2-10mm @ 532nm (Q)
	1-10 @ 2-10mm @1064nm (SLP)	10-20@ 1-10mm @ 1064 nm (SLP, Non Q)
	1-10 @ 8-10mm @1064 nm (BLUE T)	10-18 @ 8-10mm, @ 1064nm (Blue Toning, PTP)
	1-15 @ 2-7 mm @ 1064 nm (BLUE T)	10-20 @ 2-7mm @ 1064nm (Blue Toning, PTP)

Aiming Beam	<3 mW @ 655 nm	<3 mW @ 655 nm	Same
Cooling system	Water cooling	Water cooling	Same
Dimensions	270 x 700 x 750 mm	295 x 740 x 1680 mm	Comparable
Weight	90 kg	70 kg	Comparable

The majority of the technical parameters of subject device are comparable to and/or fall within the range of the corresponding technical parameters of the predicate device, Since the maximum repetition rate for the subject device is lower than that of the predicate device, the energy delivered by the subject device is lower

Than or comparable to the predicate device. Thus, difference are not expected to significantly alter the safety

and effectiveness of the subject device compared to the predicate device

8.Performance test

Clinical data is not required in this submission, but manufactured in accordance with below both mandatory and voluntary standards, performance test data attached.

AAMI/ANSI ES60601-1:2005® 2012 And A1:2012

part 1 : General requirement for basic safety and essential performance.

IEC60601-1-2: 2014 Electro Magnetic Compatibility test

IEC60601-2-22 Part 2, Particular requirements for safety of diagnostic and Therapeutic laser IEC60825-1 :2nd ED, Equipment classification and requirement.

IEC60601-2 Part 6 General requirements for safety * Collateral Standard: Usability

Software Verification and Validation test was conducted and documentation provided as recommended by FDA guidance and IEC62304. Device software verification and validation result were found acceptable for software release

Biocompatibility

This device are meant non-contacted mode. Hand piece tips has guard which are made by S.S.304 same as predicate device.

9. Conclusion.

IRIS Pi Q-Switched Nd: YAG laser system, in this submission is the same or similar to the predicate device in respect to the Intended use, Main function, Technology, Principal operation and performance, although, there are minor different in Pulse Energy and Repetition rate, every performed safety test report show it as safe and effective as predicate device and, it does not raise any additional issues for safety and effectiveness.

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.