Who is the manufacturer of NOABLE LASER?

Daeju Meditech Engineering Co., Ltd. filed the 510(k) submission for NOABLE LASER (K242207).

What is the FDA product code for NOABLE LASER?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for NOABLE LASER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like NOABLE LASER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NOABLE LASER

K242207 · Daeju Meditech Engineering Co., Ltd. · GEX · Mar 7, 2025 · General, Plastic Surgery

Device Facts

Record ID	K242207
Device Name	NOABLE LASER
Applicant	Daeju Meditech Engineering Co., Ltd.
Product Code	GEX · General, Plastic Surgery
Decision Date	Mar 7, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia

Device Story

NOABLE LASER is a 1450nm diode laser surgical instrument for dermatological procedures. It functions by illuminating skin tissue to perform incision, destruction, and removal. The system includes a main body with a touch LCD for parameter setting and a hand-piece for laser delivery. A dynamic cooling device (DCD) sprays coolant from the hand-piece tip to protect skin from thermal damage, reducing irritation and pain. The device is operated by a clinician in a clinical setting, with laser radiation controlled via foot switch or hand-piece switch. The output allows for precise tissue ablation and vaporization. Clinical benefits include effective treatment of acne, scars, and wrinkles through controlled thermal effects.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993-1, -5, -10, -23), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), and performance testing (IEC 60601-2-22).

Technological Characteristics

Diode laser source, 1450nm wavelength, 635nm aiming beam. Features dynamic cooling device (HFC-134a). Beam delivery via optical fiber and hand-piece. Electrical: 100-240VAC, 50/60Hz. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22. User interface: Touch screen.

Indications for Use

Indicated for dermatology patients requiring soft tissue incision, excision, ablation, and vaporization with hemostasis, or treatment for back acne, atrophic acne scars, facial wrinkles, mild to moderate acne vulgaris, and sebaceous hyperplasia.

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

A-fit (K173676)

Reference Devices

CANDELA SMOOTHBEAM LASER SYSTEM (K041242)

Related Devices

K041242 — CANDELA SMOOTHBEAM LASER SYSTEM · Candela Corp. · Nov 22, 2004
K254271 — CAPRI · ORO Co., Ltd. · Feb 26, 2026
K252155 — AVAVA Skin Treatment System · AVAVA, Inc. · Oct 20, 2025
K233803 — UltraClear Laser System (N/A) · Acclaro Corporation · May 8, 2024
K014128 — CANDELA SMOOTHBEAM LASER SYSTEM · Candela Corp. · Oct 4, 2002

Submission Summary (Full Text)

{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, with the letters "FDA" in a blue square. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" in a smaller font below. March 7, 2025 Daeju Meditech Engineering Co., Ltd. % Lee April Consultant Withus Group Inc 106 Superior Irvine, California 92620 Re: K242207 Trade/Device Name: Noable 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: February 7, 2025 Received: February 7, 2025 Dear Lee April: 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 (the 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 available 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory {2}------------------------------------------------ assistance/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, Digitally signed by YAN FU -S YAN FU-S Date: 2025.03.07 09:29:02 -05'00' for Tanisha Hithe 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 {3}------------------------------------------------ # Indications for Use Submission Number (if known) K242207 Device Name NOABLE LASER Indications for Use (Describe) For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia 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) ## 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." {4}------------------------------------------------ ## 510(k) Summary #### Submitter DAEJU MEDITECH ENGINEERING CO., LTD. SEONGUN KIM #501-504, HausD Sejong Tower, 26, Seongsu-il-ro 10-gil, Seongdong-gu Seoul, Republic of Korea 04793 Email: globalsales@daejumedi.co.kr Phone: +82-2-2208-0905 ## Device Information - · Trade Name: NOABLE LASER - · Common Name: Laser Surgical Instrument - · Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology - Product Code: GEX - · Panel: General & Plastic Surgery - Regulation Number: 21 CFR §878.4810 . - · Device Class: Class II - · Date prepared: 03/06/2025 ## Predicate Device Primary Predicate K173676, A-fit manufactured by Hironic Co., Ltd. Reference K041242, CANDELA SMOOTHBEAM LASER SYSTEM manufactured by CANDELA CORP. #### Indications for use For use in dermatology: incision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia #### Device Description NOABLE LASER is a laser surgical instrument used during treatment where the laser 1450nm wavelength generated from the diode laser module. It can be used for incision, destruction and removal of skin tissue by illuminating a 1450 nm wavelength laser on the skin tissue. Based on state-of-the-art diode laser technology, the system offers many advantages, including the combination of the effective wavelengths, excellent pulse characteristics, and unique dynamic cooling device (DCD) and compact instrument. Laser is sent out through the diode laser module equipped inside the Main body to oscillate the laser and the user uses the touch LCD in the Main body and hand-piece to set the output parameters while controlling laser radiation through the foot switch and hand-piece switch. At this point, a coolant is sprayed from the end of the hand- piece to protect skin from the heat generated by the radiated laser, resulting in a reduction in skin irritation and pain. ## Official Correspondent Withus Group Inc. April Lee 106 Superior, Irvine. CA USA 92620 Email: withus6664@gmail.com Phone: +1-909-274-9971 {5}------------------------------------------------ ## Summary of Technological Characteristics | ITEM | PROPOSED DEVICE | PREDICATE DEVICE | REFERENCE DEVICE | Remark | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | NOABLE LASER | A-Fit | CANDELA SMOOTHBEAM LASER SYSTEM | | | K number | K242207 | K173676 | K041242 | | | Product Code | GEX | GEX | GEX | Same | | Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | | Indications for Use | For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia | Main Hand Piece For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia Radio Frequency Hand piece The RF Hand piece energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. | The Candela Smoothbeam Laser is indicated for the following uses: For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia | Same | | Light source | Diode Laser | Diode Laser | Diode Laser | Same | | Wavelength- Beam radiation | $1450nm {+} 10%$ | $1450nm {+} 10%$ | 1450nm | Same | | Wavelength - Beam Pointing | $635nm {+} 10%$ | $635nm {+} 10%$ | Unknown | Same | | ITEM | PROPOSED DEVICE | PREDICATE DEVICE | REFERENCE DEVICE | Remark | | Intended for | Prescription Use | Prescription Use | Prescription Use | Same | | Maximum laser output | 4 J/cm2 - 12 J/cm2 ± 20% (STAMPING mode) 4 J/cm2 - 8 J/cm2 ± 20% (TONING mode) | 4 J/cm2 - 13 J/cm2 ± 20% (Soft and Normal modes) | 8-25 J/cm2 | Similar | | Maximum laser output – Beam pointing | < 5 Mw | < 5 Mw | Unknown | Same | | Maximum Pulse Duration (Pulse Width) | Total 250 ms(62.5 ms X 4) ± 10% Total 250 ms (4.17 ms X 60) ± 10% | Total 250 ms (62.5 ms X 4) ± 10% Total 250 ms (4.17 ms X 60) ± 10% | 210 ms | Same | | Laser radiation range - Beam radiation | 4mm, 6mm ± 20% | 6mm ± 20% | 4mm, 6mm | Same | | Pulse Repetition Rate (Hz) | STAMPING Mode: 4Hz (62.5 ms x 4 pulse) TONING Mode: 60 Hz (4.17ms x 60 pulse) | Normal Mode: 4 Hz (62.5ms x 4 pulse) Soft Mode: 60 Hz (4.17ms x 60 pulse) | 1 Hz | Similar | | Interface | Touch Screen | Touch Screen | Touch Screen | Same | | Beam Delivery System | Handpiece | Handpiece | Handpiece | Same | | Laser transmission method | Optical Fiber | Optical Fiber | Diode | Same | | Activation | Via Footswitch and hand-piece switch | Via Footswitch | Via Footswitch | Analysis 1 | | Cooling System | Cryogen Cooling Device 25 ms ~ 50 ms (5 ms ~ 10 ms x 5) | Cryogen Cooling Device 10 ms ~ 50 ms | Integrated-Spray Duration Control / Canister Counter 2 ~ 60 ms | Analysis 2 | | Electrical Requirements | 100-240VAC, 50/60Hz, 600VA | 110 V 60 Hz / 2-1A, 600 VA | 115/230 VAC 50/60Hz | Analysis 3 | | Weight | 36 kg | 48 kg | 40 lbs (18kg) | | | ITEM | PROPOSED DEVICE | PREDICATE DEVICE | REFERENCE DEVICE | Remark | | Dimensions | 420 x 420 x 1,560mm | 350 x 500 x 857mm | 431.8 x 558.8 x 508mm | | | Operation time | 10 minutes | 10 minutes | 10 minutes | Same | Original 510k Submission File {6}------------------------------------------------ Original 510k Submission File {7}------------------------------------------------ The subject and primary predicate device (K173676) are similar in indications, and principle of operation. The differences between the subject and primary predicate are discussed as below: #### Analysis 1 - Activation The Activation of the proposed device is different from predicate device. However, the activation is only concerned with the operation method of the product and this difference will not raise any issues in safety and effectiveness. Thus, the is determined to be substantially equivalent with predicate device. #### Analysis 2 - Cooling System The proposed device has a different Duration of Cooling system from the predicate device. Cooling System (HFC-134a is raw material of Cooling System) is same. And duration of proposed devices is within the duration of cooling system of predicate device. Thus, the proposed device is determined to be substantially equivalent with predicate device. #### Analysis 3 - Electrical Requirements, Weight and Dimensions The Electrical Requirements, Weight and Dimensions for the are different from predicate device. However, the difference is just in electrical and physical specification and this difference will not raise in safety and effectiveness. Thus, the difference is considered would not raise any issues in safety and effectiveness. And the proposed device has passed the EC 60601-1-22, IEC 6082-1 test and performance test in IEC 60601-1 test, the safety and performance of the product can be ensured. {8}------------------------------------------------ ## Non-clinical Testing Non-clinical tests were conducted to verify that the proposed device met all design specification as was substantially equivalent (SE) to the predicate device. #### Biocompatibility Testing The biocompatibility evaluation for the subject device was conducted in accordance with the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing including cytotoxicity, Sensitization and Irritation are conducted according to the ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Biocompatibility testing of NOABLE LASER is as below; a) ISO 10993-5:2009 - Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity b) ISO 10993-10:2021 - Biological Evaluation of Medical Devices - Part 10: Tests for skin sensitization. 6.5 Guinea pig maximization test(GPMT) c) ISO 10993-23:2021 - Biological Evaluation of Medical Devices - Part 23: Tests for irritation, 7.2 Animal irritation test bv skin exposure ## Electrical Safety and electromagnetic Compatibility (EMC) Electrical safety and EMC testing were conducted on Laser Surgical Instrument. The device complies with the following standards - IEC 60601-1: 2005+A2:2020 Medical electrical equipment Part 1: General requirements for basic . safety and essential performance. - . IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests - IEC 60825-1:2014 Safety of laser products Part 1: Equipment classification and requirements . #### Particular Performance Testing Performance testing was conducted on the device according to the following standard: - IEC 60601-1: 2005+A2:2020 Medical electrical equipment Part 1: General requirements for basic ● safety and essential performance. - . IEC 60601-2-22:2019 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment #### Software Verification and Validation Testing The software for this device was considered as a "Moderate" level of concern. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". #### Accuracy Testing The accuracy test was conducted to verify that the energy output and laser radiation range of the proposed laser system do not deviate the tolerance of the setting value of energy output or the fixed value of range. The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device. {9}------------------------------------------------ # Clinical Testing Not applicable. ## Conclusion Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.