PICORE Q-switched Nd : Y AG Laser System is indicated for the incision, 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

Device Description

The subject device PICORE is a picosecond Nd:Y AG laser instrument that uses Nd:YAG as a medium to emit a laser beam of 1064nm and 532nm wavelength. It has four non-fractional handpieces (Zoom handpiece, 7mm collimated handpiece, 3-5 mm handpiece, 6-8 mm handpiece). A physician can optimize the treatment effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam. Laser emission can be controlled by using a Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device (BM.IRIS, K171648) by showing that its technical specifications are comparable and that it passed relevant non-clinical testing standards.

However, we can infer the "acceptance criteria" through the comparison to the predicate device and the non-clinical testing performed.

Acceptance Criteria (Inferred)	Reported Device Performance (PICORE, K212082)
Technical Specifications Comparable to Predicate Device (BM.IRIS, K171648):
Laser Type	Nd:YAG (Same as predicate)
Wavelength (nm)	1064/532 (Same as predicate)
Operating Mode	Q-switched, Pulsed (Same as predicate)
Spot size (mm)	2-10 @ 1064nm, 2-10 @ 532nm (Comparable to predicate's 2-10 @ 1064nm, 1.5-8 @ 532nm)
Maximum Pulse Energy (mJ)	50-800 @ 1064nm (Q), 5-300 @ 532nm (Q), 50-800 @ Blue Fx, 50-800 @ Blue T (Different from predicate's 1200 @1064nm (Q), 400 @ 532nm (Q), etc., but noted as "different & subset" with an implication of maintaining safety/effectiveness).
Maximum Pulse Power (GW)	800 mJ/450ps = 1.8 GW (Different from predicate's 1200 mJ/5ns = 0.24 GW, but deemed not to significantly alter safety/effectiveness).
Pulse Duration	450 ps @ 1064nm, 380 ps @ 532nm, 450 ps @ Blue Fx, 450 ps @ Blue T (Different from predicate's 5-10ns, but deemed not to significantly alter safety/effectiveness).
Repetition Rate (Hz)	1-10 (Different from predicate's 10-20, but noted as "different & subset" with an implication of maintaining safety/effectiveness).
Aiming Beam	<3 mW @ 655 nm (Same as predicate)
LCD Display	10.4" touch screen (Same as predicate)
Cooling	Closed circuit water to air (Same as predicate)
Power Consumption	3kVA (Same as predicate)
Dimensions	290mmX794mmX934mm (Comparable to predicate's 295mmX740mmX1680mm)
Weight	60 kg (Comparable to predicate's 70 kg)
Compliance with Non-Clinical Standards:
Basic Safety & Essential Performance (IEC 60601-1)	Met (Test conducted)
Laser Product Safety (IEC 60825-1)	Met (Test conducted)
Electromagnetic Compatibility (IEC 60601-1-2)	Met (Test conducted)
Software Validation & Verification	Met (Test conducted)
Bench Testing to Verify Performance	Met (Test conducted)
Biocompatibility: (Not performed, rationale provided)	Not applicable: Handpieces do not touch patients and are identical to the predicate device.
No Significant Alteration in Safety and Effectiveness due to Technical Differences from Predicate	The document explicitly states: "The difference in technological parameters is not expected to significantly alter the safety and effectiveness of the subject device compared to the predicate device." This is the overarching acceptance criterion for substantial equivalence.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. No clinical or standalone performance studies were conducted that would involve a "test set" of patients/data in the typical sense for an AI/diagnostic device. The testing was non-clinical (bench testing, standards compliance).
Data Provenance: Not applicable. The testing was primarily against hardware/software standards and direct comparison of specifications, not clinical data or patient samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. Since no clinical study or data-driven performance test was conducted on a "test set" requiring ground truth, no experts were used for this purpose in the context of this submission.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical or data-driven test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done.
Effect Size of Human Readers with AI vs. without AI assistance: Not applicable, as no such study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Standalone Performance Study: No, a standalone performance study (algorithm only) was not conducted. The device is a laser system, not an AI or diagnostic algorithm, and its performance is evaluated through technical specifications and safety standards, not an "algorithm only" assessment.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable in the context of clinical outcomes or diagnostic accuracy. For the non-clinical testing, the "ground truth" was established by engineering specifications, recognized international safety and performance standards (IEC standards), and the technical characteristics of the legally marketed predicate device.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a laser system, not a machine learning or AI-driven diagnostic device that typically requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable, as no training set was used.

Summary

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October 6, 2021

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

Re: K212082

Trade/Device Name: Picore 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 1, 2021 Received: September 8, 2021

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.

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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) K212082

Device Name PICORE

Indications for Use (Describe)

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

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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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of 21CFR Section 807.92.

The assigned 510(k) Number: K212082

Date of Preparation 1. 10/05/2021

2.	ApplicantName:Contact Name:Address:Telephone:Fax:Email:	Bio-Med USA Inc.Young Chi, C.E.O.27 New England Drive, Ramsey, NJ 07446. U.S.A.1 973 278 52221 201 934 6030biomedusa@msn.com
3.	ManufacturerName:Address:Telephone:Fax:Registration #	BlueCore Co., Ltd.Acehigh 21, 48 Centum-Jungang ro 12, Haeundae Gu, Busan, Rep of Korea.82 51 747 431882 51 747 43193014144061

1. Identification of the Proposed Device Trade/Device Name: PICORE Common Name: Nd:YAG O-switched Surgical Laser Classification Name: Powered Laser Surgical Instrument Classification: II Product Code: GEX Regulation Number: 21 CFR 878.4810
  General& Plastic Surgery
1. Identification of Predicate Device 510(k) Number: K171648 Trade/Device Name: BM.IRIS Manufacturer: BlueCore Co. Ltd.
Device Description 6.

Review Panel:

1. Indications for Use - The indications for use statement of the subject device PICORE is given below. The indications for use of the PICORE is comparable to the indications for use of the predicate device BM.IRIS (K171648). Both devices are for prescription use only.
  PICORE 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

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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:

1. Substantially Equivalent (SE) Comparison

Tab 1 Technical Comparison
Technical Specification	Subject Device(K212082)	Predicate Device(K171648)	Comment
Laser Type	Nd:YAG	Nd:YAG	same
Wavelength (nm)	1064/532	1064/532	same
Operating Mode	Q-switched, Pulsed	Q-switched, Pulsed	same
Mode Names	1064, 532, Blue Fx, BlueT	1064, 532, SLP, BlueToning
Spot size (mm)	2-10 @ 1064nm2-10 @ 532nm	2-10 @ 1064nm1.5-8 @ 532nm	comparable
Maximum Pulse Energy (mJ)	50-800 @ 1064nm (Q)5-300 @ 532nm (Q)50-800 @ Blue Fx50-800 @ Blue T	1200 @1064nm (Q)400 @ 532nm (Q)1500 @ 1064 nm (SLP, Non Q)1000 @ 1064nm (BlueToning, PTP)	different &subset
Maximum Pulse Power (GW)	800 mJ/450ps = 1.8 GW	1200 mJ/5ns = 0.24 GW	different
Pulse Duration	450 ps @ 1064nm380 ps @ 532nm450 ps @ Blue Fx450 ps @ Blue T	5-10ns @1064nm (Q)5-10ns @ 532nm (Q)5-10ns @ 1064 nm (SLP, Non Q)5-10ns @ 1064nm (BlueToning, PTP)	different
Repetition Rate (Hz) @ spotsize (mm)	1-10	10-20 @ 2-10mm@1064nm (Q)10-20 @ 2-10mm @532nm (Q)10-20@ 1-10mm @ 1064nm (SLP, Non Q)10-20 @ 2-7mm @1064nm10-18 @ 8-10mm, @1064nm (Blue Toning,PTP)	different &subset
Aiming Beam	<3 mW @ 655 nm	<3 mW @ 655 nm	same
LCD Display	10.4" touch screen	10.4" touch screen	same
Cooling	Closed circuit water to air	Closed circuit water to air	same
Power Consumption	3kVA	3kVA	same
Dimensions	290mmX794mmX934mm	295mmX740mmX1680mm	comparable
Weight	60 kg	70 kg	comparable

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Majority of the technical parameters of the subject device are comparable to and/or fall within the range of the corresponding technical parameters of the primary predicate device. The difference in technological parameters is not expected to significantly alter the safety and effectiveness of the subject device compared to the predicate device.

1. Non-Clinical Testing
  Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. Biocompatibility testing was not performed since the handpieces of the subject device do not touch patients and are exactly the same as in the predicate. The following tests were conducted:
▲ IEC 60601-1:2005/A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance;
A IEC 60825-1: 2014, Safety of laser products - Part 1: Equipment classification and requirements.
IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
A Software Validation & Verification Test
Bench Testing to verify the performance
1. Clinical Testing

No clinical study is included in this submission.

1. Conclusion
  Based on the comparison and analysis above, the proposed subject device is determined to be Substantially Equivalent (SE) to the predicate device.

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.