K2 mobile laser is intended for use by dentists for excision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The Specific indications are as follows:

Endodontic procedures: Pulpotomy, Root canal therapy

Periodontal procedures: Sulcular debridement

Implant procedures: Implant recovery

Surgery procedures:

Biopsies, Crown lengthening, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Gingivoplasty, Incision and drainage of abscess, Operculectomy, Papillectomies, Reduction of gingival hypertrophy, Vestibuloplasty

Other procedures:

Gingival troughing, Hemostasis and coagulation, Leukoplakia,

Treatment of aphthous-ulcer canker sores and herpetic,

Laser Assisted whitening,

Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor muscular back pain; the temporary increase in local blood circulation; the temporary relation of muscle

Device Description

The dental diode laser (Model: K2 MOBILE) is a surgical device designed for a wide variety of dental soft tissue procedures. Diode laser is used as a source of invisible infrared radiation for this device and delivered to the treatment area through optical fiber is incorporated into a tip. The dental diode laser (Model: K2 MOBILE) is handpiece type using an internal rechargeable battery. The rechargeable battery charger are provided.

AI/ML Overview

The provided text describes the K2 Mobile, a dental diode laser, and establishes its substantial equivalence to predicate devices (Photon Plus and iLaseTM) based on various performance and safety criteria. However, it does not include a table of acceptance criteria and reported device performance in terms of clinical accuracy metrics (e.g., sensitivity, specificity, AUC) or human reader performance with/without AI assistance. The document focuses on showing that the K2 Mobile meets safety and electrical standards and shares similar technical specifications and intended use with the predicate devices. Therefore, much of the requested information cannot be extracted directly from this document.

Here's a breakdown of what can be inferred and what is not available:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the context of clinical performance metrics, nor does it report specific clinical performance values for the K2 Mobile. Instead, equivalence is established by demonstrating that the device meets recognized safety and performance standards (like IEC 60825-1, IEC 60601-1, IEC 60601-2-22, 21CFR1040.10, 21CFR1040.11, IEC 62133, IEC 60601-1-2), and that its specifications fall within acceptable ranges compared to the predicate devices.

Table of Technical Specifications and Comparison for Substantial Equivalence:

Feature	Acceptance Criteria (Predicate)	K2 Mobile Reported Performance	Comparison
Product Code	GEX	GEX	Same
Regulatory Class	2	2	Same
Indications for Use	Similar indications to PD1 (Photon Plus) and PD2 (iLaseTM), covering various oral soft tissue procedures, tooth whitening, and pain relief.	Similar to predicate devices, included in PD1's indications.	Equivalent
Principle of Operation	Laser diode as source of invisible infrared radiation delivered via optical fiber.	Same	Same
Laser Medium	Diode Laser	Diode Laser	Same
Laser Classification	Class IV (4) Laser	Class IV (4) Laser	Same
Laser Wavelength	980nm (PD1), 940nm (PD2)	980nm	Same as PD1
Laser Power Range	0-10W (PD1), 0-5W (PD2)	0-6W (max 3.5W CW, max 6.0W pulsed)	Equivalent (within PD1 range, similar to PD2)
Operation Mode	Continuous (CW), Pulse mode	Continuous (CW) mode, Pulse mode	Same
Pulse Width/Interval	0.1ms to 9.9s (PD1)	On/off time: 50ms (Pulse mode 1), 5ms (Pulse mode 2)	Equivalent (within PD1 range)
Pulse Repetition Rate	1Hz to 5,000Hz (PD1)	10Hz (Pulse mode 1), 100Hz (Pulse mode 2)	Different (but deemed safe/effective after testing)
Aiming Beam	650nm, 2mW (PD1); 635nm, 5mW (PD2)	635nm, 5mW	Same as PD2
Fiber Core Diameter	400 μm	400 μm	Same
Power Input	Rechargeable Li-polymer 7.4V, 5A (PD1); Rechargeable Li-ion 3.6V, 650mA (PD2)	Rechargeable Li-ion 3.7V, 1700mA	Different (but deemed safe/effective after testing)
Prescription/OTC	Prescription	Prescription	Same
Intended User	Licensed practitioner	Licensed practitioner	Same
Safety and Performance	Compliance with specified IEC/CFR standards	Tested per IEC 60825-1, IEC 60601-1, IEC 60601-2-22, 21CFR1040.10, 21CFR1040.11, IEC 62133, IEC 60601-1-2	Compliant
Biocompatibility	Compliance with ISO 10993 series	Tested per ISO 10993-1, -5, -10, -11, -4	Compliant
Reprocessing	Compliance with FDA reprocessing guidance	Validated reprocessing process found effective	Compliant

Study Information (as extractable from the provided text):

Sample size used for the test set and the data provenance:
- The document describes non-clinical performance testing (laser performance, output power, electrical safety, EMC, biocompatibility, reprocessing). It does not mention a "test set" in the context of clinical data for algorithmic performance.
- Data Provenance: Not applicable as no clinical trial or algorithm evaluation data is provided. The tests appear to be laboratory-based and engineering compliance tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is defined by engineering and safety standards, not clinical expert consensus on diagnostic or treatment outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept applies to clinical studies where expert consensus is needed to establish a ground truth for a diagnostic outcome.
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:
- No. The document describes a medical device (laser surgical instrument), not an AI/CADe (Computer-Assisted Detection) or CADx (Computer-Assisted Diagnosis) device. Therefore, MRMC studies are not relevant in this context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance and safety tests, the "ground truth" is adherence to established international and national standards (e.g., IEC 60825-1, IEC 60601-1, 21CFR1040.10, ISO 10993 series) and the specifications of predicate devices.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set."
How the ground truth for the training set was established:
- Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

November 19, 2020

HULASER, Inc. % Dongha Lee Regulatory Affairs Consultant KMC, Inc. Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul, 08375 Korea, Republic Of

Re: K200693

Trade/Device Name: K2 Mobile 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: March 10, 2020 Received: March 16, 2020

Dear Dongha Lee:

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 (OS) 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 medical devices and radiation-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 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) K200693

Device Name K2 MOBILE

Indications for Use (Describe)

Endodontic procedures: Pulpotomy, Root canal therapy

Periodontal procedures: Sulcular debridement

Implant procedures: Implant recovery

Surgery procedures:

Other procedures:

Gingival troughing, Hemostasis and coagulation, Leukoplakia,

Treatment of aphthous-ulcer canker sores and herpetic,

Laser Assisted whitening,

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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Image /page/3/Picture/0 description: The image shows the logo for HU Laser, which includes a red cross symbol integrated into the "H" of the company name. The text "LASER SCIENCE FOR HUMANS" is written in smaller font below the company name. To the left of the logo, the text "SINCE 2002" is written vertically.

510(k) Summary (K200693)

This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: September 28, 2020

1. Applicant / Submission Sponsor

HULASER, Inc. Address: 1110, DAERUNG TECHNOTOWN 17, 25, GASAN DIGITAL 1-RO, GEUMCHEON-GU, SEOUL, 08594, KOREA Tel: +82-2-3012-5678 Fax: +82-2-544-6540

2. Submission Correspondent

DongHa Lee (Consultant, KMC, Inc.) Address: Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu, Seoul, 08375, Korea Tel: +82-70-8965-5554 Fax: +82-2-856-5904 Email: dhlee@kmcerti.com

3. Device Identification

Trade/Proprietary Name: K2 MOBILE Common Name: Dental Diode Laser Classification Regulation: 21CFR 878.4810 Product Code: GEX, Device Class: 2

4. Predicate Devices

	Predicate Device 1	Predicate Device 2
Manufacturer	Zolar Technology Inc	Biolase Technology, Inc.
Device Name	Photon Plus	iLaseTM
510(k) number	K162114	K093852

5. Description

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Image /page/4/Picture/0 description: The image is a logo for "HU LASER", with the tagline "LASER SCIENCE FOR HUMANS". The logo features the letters "HU" in a bold, sans-serif font, with a red cross symbol incorporated into the "U". To the left of the "HU" is the text "SINCE 2002" in a smaller font size, arranged vertically. The words "LASER SCIENCE FOR HUMANS" are placed below the "HU LASER" text, also in a sans-serif font.

incorporated into a tip. The dental diode laser (Model: K2 MOBILE) is handpiece type using an internal rechargeable battery. The rechargeable battery charger are provided.

6. Indication for use

Endodontic procedures:

Pulpotomy, Root canal therapy

Periodontal procedures:

Sulcular debridement

Implant procedures:

Implant recovery

Surgery procedures:

Biopsies, Crown lengthening, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Gingivoplasty, Incision and drainage of of abscess, Gingivectomy, Operculectomy, Papillectomies, Reduction of gingival hypertrophy, Vestibuloplasty

Other procedures:

Gingival troughing, Hemostasis and coagulation, Leukoplakia,

Treatment of aphthous-ulcer canker sores and herpetic,

Laser Assisted whitening,

Topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relation of muscle

7. Substantial Equivalence

Dental Diode Laser (Model: K2 MOBILE) is substantially equivalent to the predicate devices, Photon Plus (K162114, Zolar Technology Inc) and iLaseTM (K093852, Biolase Technology, Inc.) The following comparison table is presented to demonstrate substantial equivalence.

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	Subject Device	Predicate Device 1 (PD1)	Predicate Device 2 (PD2)	Comparison
Manufacturer	HULASER, Inc.	Zolar Technology Inc	Biolase Technology, Inc.	-
Device Name	K2 MOBILE	Photon Plus	iLaseTM	-
510(k) number	K200693	K162114	K093852	-
Product Code	GEX	GEX	GEX	Same
Regulatory Class	2	2	2	Same
Indications for Use	K2 mobile laser is intended for useby dentists for excision, incision,vaporization, ablation andcoagulation of oral soft tissueprocedures, including ToothWhitening and the temporary reliefof pain. The Specific indications areas follows:Endodontic procedures:Pulpotomy,Root canal therapyPeriodontal procedures:Sulcular debridementImplant procedures:Implant recoverySurgery procedures:Biopsies,Crown lengthening,Exposure of unerupted teeth,Fibroma removal,Frenectomy,Gingivectomy,Gingivoplasty,Incision and drainage of abscess	Dental Soft Tissue IndicationsIncision, excision, vaporization,ablation and coagulation of oral softtissues including marginal and inter-dental gingival and epithelial liningof free gingival and the followingspecific indications:Exposure of Unerupted teethFibroma removalFrenectomyGingival Troughing for crownimpressionsGingivectomyGingivoplastyHemostasis and coagulationGingival incision and excisionhemostasisImplant recoveryIncision and drainage of abscessLeukoplakiaOperculectomyOral papillectomiesPulpotomy as an adjunct to rootcanal therapyReduction of gingival hypertrophySoft tissue crown lengtheningGingival bleeding index	The iLaseTM dental soft tissue laseris a surgical device designed for awide variety of dental soft tissueprocedures and laser periodontalprocedures.Dental Soft Tissue Indications:Incision, excision, vaporization,ablation and coagulation of oral softtissues, including marginal and inter-dental gingivaland epithelial lining of free gingivaand the following specificindications:Excisional and incisional biopsiesExposure of unerupted teethFibroma removalFrenectomyFrenotomyGingival troughing for crownimpressionsGingivectomyGingivoplastyGingival incision and excisionHemostasis and coagulationImplant recoveryIncision and drainage of abscessLeukoplakia	Equivalent(Included in theindications of PD1)
	Papillectomies,Reduction of gingival hypertrophy,VestibuloplastyOthers procedures:Gingival troughingHemostasis and coagulationLeukoplakiaTreatment of aphthous-ulcer cankersores and herpeticLaser Assisted whiteningTopical heating for the purpose ofelevating tissue temperature fortemporary relief of minor muscleand joint pain and stiffness minorarthritis pain, or muscle spasm,minor sprains and minor muscularback pain; the temporary increase inlocal blood circulation; thetemporary relation of muscle	Treatment of aphthous ulcer cankersores and herpetic.Vestibuloplasty.Laser Periodontal IndicationsSulcular debridement (removal ofdiseased or inflamed soft tissue inthe periodontal pocket to improveclinical indices including: probedepth, attachment loss and toothmobility)Removal of highly inflamededematous tissue affected bybacteria penetration of the pocketlining and junctional epithelium.Tooth Whitening IndicationsLaser Assisted whitening/bleachingof teeth.Light activation for bleachingmaterials for teeth whitening.Pain IndicationsTopical heating for the purpose ofelevating tissue temperature for atemporary relief of minor muscleand joint pain and stiffness minorarthritis pain, or muscle spasm,minor sprains and minor muscularback pain; the temporary increase inlocal blood circulation; thetemporary relaxation of muscle.	Oral papillectomiesPulpotomyPulpotomy as an adjunct to rootcanal therapyReduction of gingival hypertrophySoft tissue crown lengtheningTreatment of canker sores, herpeticand aphthous ulcers of the oralmucosa.VestibuloplastyTissue retraction for impressionLaser Periodontal Procedures,including:Laser soft tissue curettageLaser removal of diseased, infected,inflamed and necrosed soft tissuewithin the periodontal pocketSulcular debridement (removal ofdiseased, infected, inflamed andnecrosed soft tissue in theperiodontal pocket to improveclinical indices including gingivalindex, gingival bleeding index,probe depth, attachment loss andtooth mobility).
Principle of operation	Laser diode is used as a source ofinvisible infrared radiation for thisdevice and delivered to the treatmentarea through optical fiber	Laser diode is used as a source ofinvisible infrared radiation for thisdevice and delivered to the treatmentarea through optical fiber	Laser diode is used as a source ofinvisible infrared radiation for thisdevice and delivered to the treatmentarea through optical fiber	Same
Laser Medium	Diode Laser	Diode Laser	Diode Laser	Same
Laser Classification	Class IV (4) Laser	Class IV (4) Laser	Class IV (4) Laser	Same
Laser Wavelength	980nm	980nm	940nm	Same as the PD1
Laser Power range	0~6W	0~10W	0~5W	Equivalent(Included in the rageof PD1)Similar(Refer to Note 1.)
Operation mode	Continuous (CW) mode,Pulse mode	Continuous (CW) mode,Pulse mode	Continuous (CW) mode,Pulse mode	Same
Pulse width/interval	On/off time: 50ms (Pulse mode 1)On/off time: 5ms (Pulse mode 2)	0.1ms to 9.9s	Unknown	Equivalent(Included in the rageof PD1)(Refer to Note 1.)
Pulse repetition rate	10Hz (Pulse mode 1)100Hz (Pulse mode 2)	1Hz to 5,000Hz	Unknown	Different(Refer to Note 1.)
Aiming Beam	635nm, 5 mW	650nm, 2mW	635nm, 5 mW	Same as the PD2
Fiber core diameter	400 μm	400 μm	400 μm	Same
Power Input	Rechargeable Lithium Ion battery:3.7V, 1700 mA(Battery charger: AC 100-240V, 47-63Hz)	Rechargeable lithium polymerbattery: 7.4V, 5A(Battery charger: AC 100-240V,50/60Hz)	Rechargeable Lithium Ion battery:3.6V, 650 mA(Battery charger: AC 90-230V, 50-60Hz)	Different(Refer to Note 2.)
Prescription or OTC	Prescription	Prescription	Prescription	Same
Intended User	Licensed practitioner	Licensed practitioner	Licensed practitioner	Same

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Note 1.

: Laser output power range of the subject device is 0 to 6.0W. (The maximum output power is 3.5W on CW mode and the maximum peak power is 6.0W on pulsed model) The range is within the range (0 to 10W) of the predicate device 1 (K16214) and similar to the predicate device 2 (K093852, 0 to 5W). Pulse width/interval and pulse repetition rate of that onloff time is 50ms (10Hz) on pulse mode 1 and onloff time is 5ms (100Hz) on pulse mode 2. The predicate device 1 (K162114) has a specification of the pulse repetition rate (0.1ms to 9.9s 1Hz to 5,000Hz). The specifications of the predicate device 2 (K093852) is unknown.

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The laser safety and performance test was conting to IEC 60825-1. The device safety and performance test was conducted acording to IEC 60601-1, IEC 60601-2-2, 21CFR1040.10 and 21CFR1040.11 with the above differences. The testing results show that these differences do not raise different questions of safety and effectiveness.

(The safety and performance test reports are attached in this submission).

Note 2.

: The subject device uses an internal rechargeable lithium-ion battery (DC 3.7V,1700mA). The predicate device 1 (K16214) uses an internal rechargeable lithium-polymer battery (DC 7.4V, 5A), and the predicate device 2 (K093852) uses an internal recharged be lithing-ion battery (DC 3.6V, 650mA).

The internal battery and performance test was conding to IEC 62133. The device safety and performance test was conducted according to IEC 60601-1 and IEC 60601-2-22. The testing results show that these different questions of safety and effectiveness. (The safety and performance test reports are attached in this submission).

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8. Reprocessing

We tested and validated the reprocessing process according to FDA reprocessing guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.". The results show that the designed reprocessing processes are effective to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization.

9. Biocompatibility

The biocompatibility tests of patient contact part (Tip, optical fiber is incorporated into tip, External communicating device - Blood path, indirect / limited contact duration: <24 hours) were performed in accordance with the following FDA recognized standards

ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro । cytotoxicity
-ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
-ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood

10. Electrical Safety and Electromagnetic compatibility

The Electrical Safety and Electromagnetic compatibility tests were performed in accordance with the following FDA recognized standards.

-IEC 60601-1:2005+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-22:2007+A1:2012, Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency.
-IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements
-21 CFR 1040.10 and 1040.11
IEC 62133:2012, Secondary cells and batteries containing alkaline or other non-acid electrolytes. Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
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

11. Performance Testing - Nonclinical

Laser performance - Classification, Accessible emission level

The test was performed in in accordance with the FDA recognized standard, IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements, Clause 9, and 21CFR1040.10.

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Laser output power testing - Protection against unwanted and excessive output, Accuracy of control

The test was performed in accordance with the FDA recognized standard, IEC 60601-2-22:2007+A1:2012, Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment, Clause 201.10 and 201.12, and 21CFR1040.11

12. Conclusion

In comparing between the subject device and the predicate device, there are the same product code, regulatory classification, indications for use, principle of operation, laser classification, laser medium, laser operation mode, using a rechargeable battery, prescription use and intended user. Although there are some differences (laser output specifications and internal battery specifications), the safety and performance test reports are supported to the safety and effectiveness of the subject device.

In this regard, we conclude that the subject device is substantially equivalent to the predicate devices.

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.