Excision and Incision Biopsies
Hemostatic assistance
Treatment of Apthous Ulcers
Frenectomy
Frenotomy
Gingival Incision and Excision
Gingivectomy
Gingivoplasty
Incising and Draining of Abscesses
Operculectomy
Oral Papillectomy
Removal of Fibromas
Soft Tissue Crown Lengthening
Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
Tissue retraction for Impression
Vestibuloplasty
Laser assisted whitening/bleaching of teeth
Light activation for bleaching materials for teeth whitening

Device Description

The proposed devices, MIRA LASERS ZENO 2 and MIRA LASERS ZENO 4, are new device for 510(k) submission and share the same indication for use and safety compliance, similar design features and functional features with the predicate device.

The proposed device are designed to be compact, portable, reliable and user-friendly. It provides the practitioner with a versatile instrument for applications ranging from excisions and vaporization of tissues to periodontal treatments and tooth whitening. The MIRA LASERS at 810mm are delivered through a flexible optical fiber, or fixed disposable tip. The systems may be utilized for a wide variety of dental surgical and cosmetic procedures.

The proposed devices include two models, the difference of the two models is only laser power, the laser power of ZENO 2 is 0.6W/1.2W/1.8W, and the laser power of ZENO 4 is 1.0w/2.0/3.5W.

The MIRA LASERS are contained within a compact lightweight plastic/metal housing and consists of a laser diode assembly with a self-contained cooling system, a slim battery pack, front panel display all connected to a circuit board, which controls laser output power and other system parameters for laser proper functioning.

The proposed device includes two different working modes, which are continuous wave and 20Hz pulse.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the MIRA LASERS ZENO 2/ZENO 4, based on the provided text:

Acceptance Criteria and Device Performance

This submission is a Traditional 510(k) for a laser surgical instrument. Traditional 510(k)s rely on demonstrating substantial equivalence to a predicate device, rather than defining novel performance acceptance criteria with specific metrics. The "acceptance criteria" here therefore refer to meeting design specifications and complying with relevant standards to demonstrate equivalence.

Acceptance Criteria Category	Description/Reported Device Performance
Design Specifications	The proposed device met all design specifications.
Substantial Equivalence (General)	The device was determined to be Substantially Equivalent (SE) to the predicate devices (Dental Laser Therapy System K113212 and Picasso™ K083142) in respect of safety and effectiveness.
Intended Use Equivalence	The proposed devices share the same indication for use as the predicate devices.
Safety Compliance	The proposed devices share similar safety compliance with the predicate device.
Design Features Equivalence	The proposed devices share similar design features with the predicate device.
Functional Features Equivalence	The proposed devices share similar functional features with the predicate device. The proposed devices are designed to be compact, portable, reliable, and user-friendly.
Standard Compliance (IEC 60601-1)	Complies with IEC 60601-1: 1988 +A1:1991+A2:1995 (Medical Electrical Equipment - Part 1: General requirements for safety).
Standard Compliance (IEC 60601-1-2)	Complies with IEC 60601-1-2: 2001 + A1:2004 (Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests).
Standard Compliance (IEC 60601-2-22)	Complies with IEC 60601-2-22: 2007 (Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmotic, therapeutic and diagnostic laser equipment).
Standard Compliance (IEC 60825-1)	Complies with IEC 60825-1:2007 (Safety of laser products - Part 1: Equipment classification, and requirements).
Laser Power (Specific to ZENO 2/ZENO 4)	ZENO 2: 0.6W/1.2W/1.8W ZENO 4: 1.0W/2.0W/3.5W (Note: this is a differential characteristic from the predicate, but part of the design specification for the proposed devices, not a performance metric against a defined threshold from the predicate)
Working Modes (Specific to ZENO 2/ZENO 4)	Continuous wave and 20Hz pulse.
Delivery System (Specific to ZENO 2/ZENO 4)	Delivered through a flexible optical fiber, or fixed disposable tip.
Housing/Components (Specific to ZENO 2/ZENO 4)	Compact lightweight plastic/metal housing, laser diode assembly with self-contained cooling, slim battery pack, front panel display, circuit board for control.

Study Information

Sample size used for the test set and the data provenance:
- No specific clinical test set or data provenance (e.g., country of origin, retrospective/prospective) is mentioned.
- The submission relies on "Bench tests" which are laboratory-based and do not involve human or animal subjects in the way a traditional clinical study would.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission is for a laser surgical instrument, and the non-clinical tests involved verifying design specifications and compliance with standards, not establishing ground truth for diagnostic or clinical outcome data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical test set requiring adjudication.
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 device is a laser surgical instrument, not an AI-assisted diagnostic or imaging device. No MRMC study was mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device (laser surgical instrument), not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission would be the established engineering and safety standards (e.g., IEC 60601 series, IEC 60825-1) and the verified design specifications of the device. The device was tested against these known standards and specifications.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for such a device would refer to its design and development process, which is not quantified by a training set sample size.
How the ground truth for the training set was established:
- Not applicable for the same reason as above. The "ground truth" for the development of such a device is rooted in established engineering principles, material science, and regulatory safety/performance requirements for medical lasers.

Summary

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Section III 510(k) Summary

Traditional 510(K)-MIRA LASERS - ZENO 2/ ZENO 4

1 5 2013

Section 111 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number:

l. Date of Submission: September 17, 2012
1. Sponsor

MIRA LASERS LLC 10340 Pleasant Street, Noblesville, IN 46060

Contact Person: Chad Playford Position: President Tel: 888-546-6472 Fax: 317-674-1033 Email: Chad(@miralasers.com

1. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
1. Proposed Device Identification

Proposed Device Name: MIRA LASERS Proposed Device Model: ZENO 2, ZENO 4 Common Name: Laser System

Classification: 2 Product Code: GEX Classification Name: powered laser surgical instrument Regulation Number: 21 CFR 878.4810 Review Panel: General and Plastic Surgery

Intended Use Statement:

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K123004

Section III 510(k) Summary

The MIRA LASERS is indicated for incision, excision, hemostasis, coagulation and vaporization of soft tissue including the following indications:

0 Excision and Incision Biopsies
. Hemostatic assistance
. Treatment of Apthous Ulcers
. Frenectomy
. Frenotomy
. Gingival Incision and Excision
Gingivectomy
. Gingivoplasty
. Incising and Draining of Abscesses
0 Operculectomy
Oral Papillectomy
0 Removal of Fibromas
. Soft Tissue Crown Lengthening
. Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
. Tissue retraction for Impression
. Vestibuloplasty
. Laser assisted whitening/bleaching of teeth
. Light activation for bleaching materials for teeth whitening
Predicate Device Identification 5.

510(k) Number: K113212

Product Name: Dental Laser Therapy System Manufacturer: China Daheng Group, Inc.

510(k) Number: K083142 Predicate Device Name: Picasso™ Manufacturer: AMD LASERSTM, LLC

ર. Device Description
The proposed devices, MIRA LASERS ZENO 2 and MIRA LASERS ZENO 4, are new device for 510(k) submission and share the same indication for use and safety compliance, similar design features and functional features with the predicate device.

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K12 3004 Page 3 of 3

Section III 510(k) Summary

The proposed devices include two models, the difference of the two models is only laser power, the laser power of ZENO 2 is 0.6W/1.2W/1.8W, and the laser power of 'ZENO 4 is 1.0w/2.0/3.5W.

The proposed device includes two different working modes, which are continuous wave and 20Hz pulse.

1. Non-Clinical Test Conclusion
  Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1: 1988 +A1:1991+A2:1995, Medical Electrical Equipment - Part 1: General requirements for safety.

IEC 60601-1-2: 2001 + A1:2004, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests IEC 60601-2-22: 2007, Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmotic, therapeutic and diagnostic laser equipment. IEC 60825-1:2007, Safety of laser products - Part 1: Equipment classification, and requirements

Substantially Equivalent Conclusion న్న :

The proposed device, MIRA LASERS, is determined to be Substantially Equivalent (SE) to the predicate devices, Dental Laser Therapy System (K113212) and Picasso134 (K083142), in respect of safety and effectiveness.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

MIRA Lasers, LLC % Mid-Link Consulting Company, Limited Ms. Diana Hong General Manager P.O. Box 237-023 Shanghai, China 200237

Re: K123004

Trade/Device Name: MIRA LASERS ZENO 2/MIRA LASERS ZENO 4 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: November 21, 2012 Received: December 10, 2012

Dear Ms. Hong:

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. 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 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

January 15, 2013

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Page 2 - Ms. Diana Hong

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section II Indications for Use

MIRA LASERS, LLC Traditional 510(K)-MIRA LASERS-ZENO 2/ ZENO 4

Section II Indications for Use

510(k) Number: K123004

Device Name: MIRA LASERS ZENO 2/ MIRA LASERS ZENO 4

Indications tor Use:

The MIRA LASERS is indicated for incision, excision, hemostasis, coagulation and vaporization of soft tissue including the following indications:

Excision and Incision Biopsies
ー Hemostatic assistance
Treatment of Apthous Ulcers -
-Frenectomy
. Frenotomy
Gingival Incision and Excision l
. Gingivectomy
Gingivoplasty l
Incising and Draining of Abscesses ●
-Operculectomy
Oral Papillectomy →
Removal of Fibromas →
Soft Tissue Crown Lengthening .
Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) -
Tissue retraction for Impression -
Vestibuloplasty .
Laser assisted whitening/bleaching of teeth ー
Light activation for bleaching materials for teeth whitening

XX PRESCRIPTION USE (Part 21 CFR 801 Subpart D)

OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.01.15 13:59:17 -05'00

(Division Sign-Off) Division of Surgical Devices 510(k) Number_K123004 Page I of 1

II-I

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.