HESTIA (L200-A)

K242946 · Senbitec Co., Ltd. · GEX · Oct 3, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K242946
• Device Name: HESTIA (L200-A)
• Applicant: Senbitec Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 3, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HESTIA is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary surgery. The HESTIA is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary surgery as follows: [Dermatology & Plastic Surgery] Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, &/or treatment of: hemangiomas (including Buccal and port wine); removal of small skin tumors; milia; basal and squamous cell carcinoma; tricoepitheliomas; syringoma Laser incision &/or excision of soft tissue for the performance of blepharoplasty. Laser incision &/or excision of soft tissue for the creation of recipient sites for hair transplantation [Podiatry] Laser ablation, vaporization &/or excision of soft tissue for the reduction, removal, &/or treatment of: verrucae vulgares/plantar (warts); Laser ablation, vaporization and/or excision in podiatry for complete and partial matrixectomy; [Otolaryngology (ENT)] Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for treatment of: polypectomy of nose and nasal passages; [Gynecology] Laser incision, ablation and/or vaporization of soft tissue in GYN for treatment of: condyloma acuminata, including cervical, genital, vulvar and perineal; hemangiomas [Genitourinary] Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include: condyloma; phimosis;

Device Story

Hestia (L200-A) is a CO2 surgical laser system (10,600nm wavelength) used for soft tissue ablation, vaporization, excision, incision, and coagulation. System components include a main body, articulated arm, hand-piece, foot switch, and power cord. The device transmits optical energy through the hand-piece to the target tissue. Operated by physicians in clinical settings, the device allows for adjustable parameters including power, pulse width, and frequency. The healthcare provider uses the laser to perform precise surgical procedures, directly affecting tissue removal or coagulation. Benefits include controlled tissue destruction for various dermatological, podiatric, ENT, gynecological, and genitourinary conditions.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1, IEC 60601-2-22), usability (IEC 62366-1), software validation (IEC 62304), and biocompatibility (ISO 10993 series).

Technological Characteristics

CO2 laser (10.6 μm); 40W max power; 1-1,000Hz frequency; 150-5000μs pulse width. Guide bar material: Aluminum Alloy A6061. Aiming beam: 655nm diode (max 3.0mW). Exposure modes: CW, Single, Pulse, U-Pulse. Sterilization: Moist heat (guide bar only). Software: IEC 62304 compliant.

Indications for Use

Indicated for soft tissue ablation, vaporization, excision, incision, and coagulation in dermatology, plastic surgery, podiatry, ENT, gynecology, and genitourinary surgery. Specific applications include skin resurfacing, tumor/lesion removal, blepharoplasty, hair transplant site creation, wart removal, matrixectomy, polypectomy, and treatment of condyloma and phimosis.

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

• Lumenis Ultrapulse Encore and Carbon Dioxide Surgical Laser and Delivery Device Accessories (K022060)

Reference Devices

• Azure (K231514)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

October 3, 2025

Senbitec Co., Ltd
% Dave Kim
Medical Device Regulatory Affairs
Mtech Group LLC
7505 Fannin St Suite 610
Houston, Texas 77054

Re: K242946
Trade/Device Name: Hestia (L200-A)
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: October 2, 2025
Received: October 2, 2025

Dear Dave Kim:

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.

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2K242946 - Dave Kim
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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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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3K242946 - Dave Kim
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

TANISHA
L. HITHE-S
Digitally signed by
TANISHA L. HITHE-S
Date: 2025.10.03
16:10:10 -04'00'

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120

Expiration Date: 07/31/2026

See PRA Statement below.

Submission Number (if known)

K242946

Device Name

HESTIA (L200-A)

Indications for Use (Describe)

The HESTIA is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary surgery.

The HESTIA is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary surgery as follows:

[Dermatology & Plastic Surgery]

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, &/or treatment of:

hemangiomas (including Buccal and port wine);

removal of small skin tumors;

milia;

basal and squamous cell carcinoma;

tricoepitheliomas;

syringoma

Laser incision &/or excision of soft tissue for the performance of blepharoplasty.

Laser incision &/or excision of soft tissue for the creation of recipient sites for hair transplantation

[Podiatry]

Laser ablation, vaporization &/or excision of soft tissue for the reduction, removal, &/or treatment of: verrucae vulgares/plantar (warts);

Laser ablation, vaporization and/or excision in podiatry for complete and partial matrixectomy;

[Otolaryngology (ENT)]

Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for treatment of: polypectomy of nose and nasal passages;

[Gynecology]

Laser incision, ablation and/or vaporization of soft tissue in GYN for treatment of: condyloma acuminata, including cervical, genital, vulvar and perineal; hemangiomas

[Genitourinary]

Incision/excision and vaporization of soft tissue in genitourinary procedures.

Applications include:

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condyloma;
phimosis;

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.

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Submitter: SENBITEC Co., Ltd.
HESTIA Traditional 510(k)

# Section 17 - 510(k) Summary K242946

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

Date: September 20, 2024

## I. 510K Applicant / Submitter:

Senbitec Co., Ltd.

304, 46-24 LS-ro 91beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea

Tel: [phone]

Fax: [phone]

## II. Submission Contact Person (Primary Correspondent Person)

Mr. Dave Kim

Mtech Group LLC

7505 Fannin St. Suite 610, Houston, TX 77054

Tel: [phone]

Email: [e-mail]

## III. Subject Device

- Trade/Proprietary Name: HESTIA (Model Name: L200-A)
- 510(k) Number: K242946
- Common Name: Powered Laser Surgical Instrument
- Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology
- Regulation: 21 CFR 878.4810
- Product Code: GEX

## IV. Predicate Device & Reference Device

### A. Predicate Device

- Proprietary Name: Lumenis Ultrapulse Encore and Carbon Dioxide Surgical Laser and Delivery Device Accessories
- 510(k) Number: K022060
- Common Name: Powered Laser Surgical Instrument
- Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology
- Regulation: 21 CFR 878.4810
- Product Code: GEX

### B. Reference Device

- Proprietary Name: Azure
- 510(k) Number: K231514
- Common Name: Powered Laser Surgical Instrument
- Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology
- Regulation: 21 CFR 878.4810

510(k) Summary
Section 17, Page 1

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Submitter: SENBITEC Co., Ltd.
HESTIA Traditional 510(k)

- Product Code: GEX

## V. Description:

This surgical laser is used for an operation to destroy and remove tissue by transmitting the optical energy of 10,600nm in wavelength, which is generated from the CO₂ Laser tube, through a hand-piece. This device is composed of a hand-piece through which laser is output to the main body, articulated arm, foot switch, and power cord.

## VI. Indications for Use

The HESTIA is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary surgery.

The HESTIA is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary surgery as follows:

### Dermatology & Plastic Surgery

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, &/or treatment of:

- hemangiomas (including Buccal and port wine);
- removal of small skin tumors;
- milia;
- basal and squamous cell carcinoma;
- tricoepitheliomas;
- syringoma

Laser incision &/or excision of soft tissue for the performance of blepharoplasty.

Laser incision &/or excision of soft tissue for the creation of recipient sites for hair transplantation

### Podiatry

Laser ablation, vaporization &/or excision of soft tissue for the reduction, removal, &/or treatment of: verrucae vulgares/plantar (warts);

Laser ablation, vaporization and/or excision in podiatry for complete and partial matrixectomy;

### Otolaryngology (ENT)

Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for treatment of: polypectomy of nose and nasal passages;

### Gynecology

Laser incision, ablation and/or vaporization of soft tissue in GYN for treatment of: condyloma acuminata, including cervical, genital, vulvar and perineal; hemangiomas

### Genitourinary

Incision/excision and vaporization of soft tissue in genitourinary procedures.

Applications include:

510(k) Summary
Section 17, Page 2

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Submitter: SENBITEC Co., Ltd.
HESTIA Traditional 510(k)

condyloma;
phimosis;

# VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

[Hestia (K242946) vs. Lumenis Ultrapulse Encore and Carbon Dioxide Surgical Laser and Delivery Device Accessories (K022060)]

The subject device [Hestia] is substantially equivalent to predicate device [Lumenis Ultrapulse Encore and Carbon Dioxide Surgical Laser and Delivery Device Accessories (K022060)]. The following comparison table is presented to demonstrate substantial equivalence.

The differences of two devices include "max. power (W)", "energy (J)", "frequency (Hz)", "spot size", "pulse width". A direct comparison is difficult because the values ["max. power (W)", "energy (J)", "frequency (Hz)", "spot size", "pulse width"] of the predicate device (Lumenis Ultrapulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories, K022060) is unknown. As this cannot be determined from the predicate device alone, an additional reference device has been selected for comparison purposes.

Among the comparison items, "Patient contact material", "sterilization", "single-use/reusable" of the predicate device (Lumenis Ultrapulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories, K022060) is also unknown.

However, not knowing this information will not affect the safety or effectiveness of the subject device (Hestia), as biocompatibility testing, user sterilization and reprocessing validation were conducted on it.

| | Subject device | Predicate Device | Remark |
| --- | --- | --- | --- |
| Manufacturer | SENBITEC Co., Ltd. | Lumenis Inc. | - |
| Common Name | Powered Laser Surgical Instrument | Powered Laser Surgical Instrument | |
| Regulation Name | Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology | Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology | - |
| Brand Name | Hestia | Lumenis Ultrapulse Encore and Carbon Dioxide Surgical Laser and Delivery Device Accessories | - |
| Device Class | Class II | Class II | - |
| CFR Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | - |
| Product Code | GEX | GEX | - |
| 510(K) Number | K242946 | K022060 | - |
| Indication for Use | The HESTIA is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary surgery.
The HESTIA is indicated for use in the performance of specific surgical applications in aesthetic | Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers (and their delivery accessories) are used to deliver light energy and are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including | Substantial Equivalence |

510(k) Summary
Section 17, Page 3

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Submitter: SENBITEC Co., Ltd.
HESTIA
Traditional 510(k)

| | Subject device | Predicate Device | Remark |
| --- | --- | --- | --- |
| | (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary. | laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.
In addition, the Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers are safe and effective when indicated for use in specific surgical applications in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. | |
| Laser Type | Carbon Dioxide (CO₂) | Carbon Dioxide (CO₂) | Same as predicate |
| Wave length (μm) | 10.6 μm | 10.6 μm | Same as predicate |
| Max. Power (W) | 40 W | Not Publicly Available | Unknown |
| Energy (mJ) | 40 W(CW mode)
1mJ ~ 150mJ(U-Pulse Mode) | Not Publicly Available | Unknown |
| Frequency (Hz) | 1Hz ~ 1,000Hz | Not publicly available | Unknown |
| Spot Size | - Surgical (F:50mm)
: Ø0.25mm ± 20%
- Surgical (F:100mm)
: Ø0.40mm ± 20% | Not Publicly Available | Unknown |
| Pulse Width | 150μs ~ 5000μs | Not publicly available | Unknown |
| Aiming beam | - Medium used: Diode (InGaAIP)
- Power: MAX 3.0mW
- Wavelength: 655nm | Not Publicly Available | Substantial Equivalence |
| Exposure Mode | CW, Single, Pulse and U-Pulse | CW, Ultra Pulse and SurgiTouch | Substantial Equivalence |
| Patient Contact Material | Guide Bar
: Aluminum Alloy Extruded Shapes -A6061 | Not publicly available | Substantial Equivalence |
| Sterilization | User Moist Heat (Only Guide Bar) | Not publicly available | Substantial Equivalence |

510(k) Summary
Section 17, Page 4

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Submitter: SENBITEC Co., Ltd.
HESTIA Traditional 510(k)

| | Subject device | Predicate Device | Remark |
| --- | --- | --- | --- |
| Single-use/Reusable | Reusable (Only Guide Bar) | Not publicly available | Substantial Equivalence |
| Type of Use | Prescription Use | Prescription Use | Same as predicate |

[Hestia (K242946) vs. Azure (K231514)]

The subject device [Hestia] is substantially equivalent to the reference device [Azure (K231514)]. The following comparison table is presented to demonstrate substantial equivalence.

| | Subject device | Reference Device | Remark |
| --- | --- | --- | --- |
| Manufacturer | SENBITEC Co., Ltd. | DAESHIN ENTERPRISE CO., Ltd. | - |
| Common Name | Powered Laser Surgical Instrument | Powered Laser Surgical Instrument | |
| Regulation Name | Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology | Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology | - |
| Brand Name | Hestia | Azure | - |
| Device Class | Class II | Class II | - |
| CFR Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | - |
| Product Code | GEX | GEX | - |
| 510(K) Number | K242946 | K231514 | - |
| Indication for Use | The HESTIA is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary surgery.
The HESTIA is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary. | Azure(DS-22CO) is intended for use in non-fractionated mode for Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry. | Substantial Equivalence |
| Laser Type | Carbon Dioxide (CO₂) | Carbon Dioxide(CO₂) | Same as reference |
| Wave length (μm) | 10.6 μm | 10.6 μm | Same as reference |
| Max. Power (W) | 40 W | 30W | Substantial Equivalence |
| Energy (mJ) | 40 W(CW mode)
1mJ ~ 150mJ(U-Pulse Mode) | 30W (CW mode)
15000mJ (Ultra mode) | Substantial Equivalence |
| Frequency (Hz) | 1Hz ~ 1,000Hz | 1Hz~500Hz | No significant difference |

510(k) Summary
Section 17, Page 5

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Submitter: SENBITEC Co., Ltd.
HESTIA Traditional 510(k)

| | Subject device | Reference Device | Remark |
| --- | --- | --- | --- |
| Spot Size | - Surgical (F:50mm): Ø0.25mm ± 20%
- Surgical (F:100mm): Ø0.40mm ± 20% | - Surgical (F:50mm): 0.20mm
- Surgical (F:100mm): 0.40mm
- Zoom Handpiece: 0.2~1.0mm | Substantial Equivalence |
| Pulse Width | 150μs ~ 5000μs | 60μs~900μs | No significant difference |
| Aiming beam | - Medium used: Diode (InGaAIP)
- Power: MAX 3.0mW
- Wavelength: 655nm | - Medium used: Diode (InGaAIP)
- Power: MAX 5.0mW
- Wavelength: 650nm | Substantial Equivalence |
| Exposure Mode | CW, Single, Pulse and U-Pulse | CW, Ultra mode | Substantial Equivalence |
| Patient Contact Material | Guide Bar
: Aluminum Alloy Extruded Shapes -A6061 | Not publicly available | Substantial Equivalence |
| Sterilization | User Moist Heat (Only Guide Bar) | Not publicly available | Substantial Equivalence |
| Single-use/Reusable | Reusable (Only Guide Bar) | Not publicly available | Substantial Equivalence |
| Type of Use | Prescription Use | Prescription Use | Same as reference |

The following information on the reference device [Azure (K231514)] has been compared with the subject device: "maximum power (W)", "energy (J)", "frequency (Hz)", "spot size" and "pulse width". There is a slight difference between the subject device (Hestia) and the reference device [Azure (K231514)] for the items 'frequency (Hz)' and 'pulse width'.

These are optional specifications that users can adjust as per their requirements and do not constitute special functions.

The subject device (Hestia) was also demonstrated in the performance tests for safety and effectiveness, and all test criteria were met.

## VIII. Performance Data

Non-clinical bench tests were performed as followings:

ISO 14971 Third Edition 2019-12 [Rec. Number 5-125]
Medical devices - Application of risk management to medical devices

IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION [Rec. Number 19-49]
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.

IEC 60601-1-2 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION [Rec. Number 19-36]
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

IEC 60601-2-22 Edition 3.0 2012-10 [Rec. Number 12-356]

510(k) Summary
Section 17, Page 6

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Submitter: SENBITEC Co., Ltd.
HESTIA Traditional 510(k)

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION [Rec. Number 5-132]
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION [Rec. Number 5-129]
Medical devices - Part 1: Application of usability engineering to medical devices

IEC 60825-1 Edition 2.0 2007-03 [Rec. Number 12-273]
Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]

IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION [Rec. Number 13-79]
Medical device software - Software life cycle processes

ISO 10993-1 Fifth edition 2018-08 [Rec. Number 2-258]
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ISO 10993-5 Third edition 2009-06-01 [Rec. Number 2-245]
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ISO 10993-10 Fourth edition 2021-11 [Rec. Number 2-296]
Biological evaluation of medical devices - Part 10: Tests for skin sensitization

ISO 10993-11 Third edition 2017-09 [Rec. Number 2-255]
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

ISO 10993-23 First edition 2021-01 [Rec. Number 2-291]
Biological evaluation of medical devices - Part 23: Tests for irritation

ISO 17665 First edition 2024-03 [Rec. Number 14-601]
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices

ISO 17664-1 First edition 2021-07 [Rec. Number 14-578]
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices

System testing (e.g., Energy Measurements, Safety Controls, Working Beam, aiming beam)

Along with the above tests, Electromagnetic Compatibility and Electrical Safety, Usability, Performance, and software validation were also conducted. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazard.

510(k) Summary
Section 17, Page 7

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Submitter: SENBITEC Co., Ltd.
HESTIA Traditional 510(k)

X. Conclusions:

Based on the information provided in this premarket notification, Senbitec Co., Ltd. concludes that the HESTIA (L200-A) is substantially equivalent to the predicate device as described herein in safety and effectiveness.

The HESTIA has the same intended use and similar indications for use as its predicate device, Lumenis Ultrapulse Encore and Carbon Dioxide Surgical Laser and Delivery Device Accessories (K022060). Further, the HESTIA has very similar technological characteristics and principles of operation as its predicate device, Lumenis Ultrapulse Encore and Carbon Dioxide Surgical Laser and Delivery Device Accessories (K022060). The minor technological differences between the subject and the predicate devices do not raise different questions of safety or effectiveness. Performance testing of the device has demonstrated that the device performs as intended and thus, is substantially equivalent.

510(k) Summary
Section 17, Page 8