Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the laser technology and its safety/performance characteristics, with no mention of AI or ML.

Therapeutic

Yes

The device is intended for various therapeutic procedures such as excision, vaporization, ablation, coagulation, and temporary relief of pain in oral soft tissues, which points to a therapeutic purpose.

Diagnostic

No

The device description and intended use clearly state that the K2 mobile laser is a surgical device used for therapeutic procedures like excision, vaporization, ablation, and coagulation, as well as for pain relief and tooth whitening. It is not described as being used to diagnose conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "dental diode laser" and describes physical components like an optical fiber, tip, handpiece, and rechargeable battery. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for surgical procedures on oral soft tissue. It describes actions like excision, vaporization, ablation, and coagulation. These are direct interventions on the patient's body.
Device Description: The device is described as a surgical device that delivers laser radiation to the treatment area through an optical fiber. This aligns with a surgical tool, not a diagnostic test.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, tissue, or other bodily fluids) or to provide information about a patient's health status based on such analysis. IVDs are designed to perform tests in vitro (outside the body) to diagnose or monitor conditions.
Anatomical Site: The device is used on the oral soft tissue, which is a direct application to the patient's body, not a sample taken from the body.

In summary, the K2 mobile laser is a surgical device used for therapeutic and procedural purposes directly on the patient, not for performing diagnostic tests on samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

GEX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oral soft tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dentists
Licensed practitioner

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K162114, K093852

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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.

1

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

2

Indications for Use

510(k) Number (if known) K200693

Device Name K2 MOBILE

Indications for Use (Describe)

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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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

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

4

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

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 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.

5

Image /page/5/Picture/0 description: The image shows the logo for HUTLASER. The logo is gray and features a red plus sign in the middle of the "U". Below the logo is the text "LASER SCIENCE FOR HUMANS". To the left of the logo is the text "SINCE 2002".

	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 use
by dentists for excision, incision,
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,
Gingivectomy,
Gingivoplasty,
Incision and drainage of abscess | Dental Soft Tissue Indications
Incision, excision, vaporization,
ablation and coagulation of oral soft
tissues including marginal and inter-
dental gingival and epithelial lining
of free gingival and the following
specific indications:
Exposure of Unerupted teeth
Fibroma removal
Frenectomy
Gingival Troughing for crown
impressions
Gingivectomy
Gingivoplasty
Hemostasis and coagulation
Gingival incision and excision
hemostasis
Implant recovery
Incision and drainage of abscess
Leukoplakia
Operculectomy
Oral papillectomies
Pulpotomy as an adjunct to root
canal therapy
Reduction of gingival hypertrophy
Soft tissue crown lengthening
Gingival bleeding index | The iLaseTM dental soft tissue laser
is a surgical device designed for a
wide variety of dental soft tissue
procedures and laser periodontal
procedures.

Dental Soft Tissue Indications:
Incision, excision, vaporization,
ablation and coagulation of oral soft
tissues, including marginal and inter-dental gingival
and epithelial lining of free gingiva
and the following specific
indications:
Excisional and incisional biopsies
Exposure of unerupted teeth
Fibroma removal
Frenectomy
Frenotomy
Gingival troughing for crown
impressions
Gingivectomy
Gingivoplasty
Gingival incision and excision
Hemostasis and coagulation
Implant recovery
Incision and drainage of abscess
Leukoplakia | Equivalent
(Included in the
indications of PD1) |
| | Papillectomies,
Reduction of gingival hypertrophy,
Vestibuloplasty

Others 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 | Treatment of aphthous ulcer canker
sores and herpetic.
Vestibuloplasty.

Laser Periodontal Indications
Sulcular debridement (removal of
diseased or inflamed soft tissue in
the periodontal pocket to improve
clinical indices including: probe
depth, attachment loss and tooth
mobility)
Removal of highly inflamed
edematous tissue affected by
bacteria penetration of the pocket
lining and junctional epithelium.

Tooth Whitening Indications
Laser Assisted whitening/bleaching
of teeth.
Light activation for bleaching
materials for teeth whitening.

Pain Indications
Topical heating for the purpose of
elevating tissue temperature for a
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 relaxation of muscle. | Oral papillectomies
Pulpotomy
Pulpotomy as an adjunct to root
canal therapy
Reduction of gingival hypertrophy
Soft tissue crown lengthening
Treatment of canker sores, herpetic
and aphthous ulcers of the oral
mucosa.
Vestibuloplasty
Tissue retraction for impression

6

Image /page/6/Picture/0 description: The image shows the logo for HU LASER. The logo is gray and features a red cross in the letter U. Below the logo, the text "LASER SCIENCE FOR HUMANS" is written in a smaller font. The text "SINCE 2002" is written vertically on the left side of the logo.

7

Image /page/7/Picture/0 description: The image shows the logo for HU Laser. The logo is gray and features a red cross in the upper left corner. Below the logo, the text "LASER SCIENCE FOR HUMANS" is written in gray. To the left of the logo, the text "SINCE 2002" is written vertically.

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.

8

Image /page/8/Picture/0 description: The image shows the logo for HU LASER. The logo is in gray and features a red cross in the upper left corner. Below the logo, the text "LASER SCIENCE FOR HUMANS" is written in a smaller font.

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).

9

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: