IRIS Pi Q switched Nd YAG laser

K221789 · Bio-Med USA, Inc. · GEX · Aug 9, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221789
• Device Name: IRIS Pi Q switched Nd YAG laser
• Applicant: Bio-Med USA, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 9, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

IRIS Pi Q-switched Nd:YAG laser system; generates 1064nm and 532nm pulsed laser beams via Nd:YAG crystal and Xe-gas lamp; energy delivered to tissue via articulated arm and adjustable spot-size handpiece. Operated by physicians in clinical settings; laser parameters and spot size controlled via front-panel display; emission activated by foot switch. Water-cooled system; handpiece tips feature S.S.304 guards. Laser energy induces tissue ablation, vaporization, or coagulation; clinical benefit includes removal of pigmented lesions, tattoos, unwanted hair, and skin resurfacing. Physician observes tissue response to optimize pulse energy and spot size settings.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including electrical safety (AAMI/ANSI ES60601-1), electromagnetic compatibility (IEC60601-1-2), laser safety (IEC60601-2-22, IEC60825-1), usability (IEC60601-2-6), and software verification/validation (IEC62304). Biocompatibility addressed via use of S.S.304 for handpiece tips, consistent with predicate.

Technological Characteristics

Nd:YAG laser; 1064nm/532nm wavelengths; Q-switched operating mode. Water-cooled; articulated arm delivery with adjustable spot-size handpieces. Handpiece tips: S.S.304. Dimensions: 270x700x750mm; Weight: 90kg. Aiming beam: <3mW @ 655nm. Software: IEC62304 compliant. Standards: AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-22, IEC60825-1.

Indications for Use

Indicated for patients requiring soft tissue incision, excision, ablation, or vaporization for general/dermatologic surgery and coagulation/hemostasis. Specific applications include tattoo removal (various colors), pigmented/vascular lesion removal (lentigines, cafe-au-lait, seborrheic keratoses, Becker's nevi, freckles, PIH, Nevus of Ota), hair removal/lightening, and skin resurfacing (acne scars, wrinkles).

Regulatory Classification

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.

Predicate Devices

• BM.IRIS Nd:YAG (K171648)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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

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 general<br>and 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

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

K221789

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## K221789

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

# 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 & Predicate<br>Device(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<br>(mJ) | 1600 @ 1064 nm (Q)<br>500 @ 532 nm (Q)<br>2000 @ 1064 nm (SLP)<br>1500 @ 1064 nm (BLUE T) | 1200 @ 1064 nm (Q)<br>400 @ 532 nm (Q)<br>1500 @ 1064 nm (SLP)<br>1000 @ 1064 nm (Blue Toning, PTP) | Different |
| Spot Size (mm) | 2-10 @ 1064 nm<br>2-10 @ 532 nm | 2-10 @ 1064 nm<br>1.5-8 @ 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.