SANDRO Dual

K200110 · Wontech Co., Ltd. · GEX · Mar 16, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K200110
• Device Name: SANDRO Dual
• Applicant: Wontech Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 16, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SANDRO Dual Laser System is indicated for the following at the specified wavelength: 755nm Temporary hair reduction. Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is defined as the long-term. stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I-VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas) 1064nm Removal of unwanted hair, for stable long term or permanent hair reduction. Permanent hair reduction is defined as the long-term. stable reduction in the number of hairs regrowing when measured at 6. 9. and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Benign pigmented and/or benign vascular lesions, such as, but not limited to port-wine stains, telangiectasia, venus and spider veins. Benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, skin tags, keratosis. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

Device Story

SANDRO Dual is a dual-wavelength (755nm Alexandrite and 1064nm Nd:YAG) laser system for dermatological procedures. Device comprises main unit, optical fiber, handpiece, and footswitch. User selects fluence and spot size via LCD touch pad; system automatically adjusts energy output. Operated by clinicians in clinical settings. Laser energy targets melanin in hair follicles or vascular/pigmented structures to achieve therapeutic effects (hair reduction, photocoagulation, scar reduction). Benefits include precise tissue targeting for various dermatological conditions. Device uses skin cooling spray (SCS) for patient comfort during treatment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Flash lamp-excited solid-state Alexandrite (755nm) and Nd:YAG (1064nm) laser. Pulse duration 0.3-100ms; repetition rate 0.5-10Hz. Skin cooling via Skin Cooling Spray (SCS). Complies with AAMI ES60601-1 (Ed 3.1), IEC 60601-1-2 (Ed 4), IEC 60601-2-22 (Ed 3), and IEC 60825-1 (Ed 3).

Indications for Use

Indicated for hair reduction, treatment of benign pigmented/vascular lesions, wrinkle treatment, scar reduction, and onychomycosis treatment in patients of all Fitzpatrick skin types (I-VI), including tanned skin.

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

• GentleMAX Family of Laser Systems (K140122)

Submission Summary (Full Text)

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May 26, 2021

Image /page/0/Picture/1 description: The image contains 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

WON TECH Co., Ltd. Lana Hong Staff of Regulatory Affairs 64 Techno 8-Ro, Yuseong-gu Daejeon, 34028 Korea, Republic Of

Re: K200110

Trade/Device Name: SANDRO Dual 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

Dear Lana Hong:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter for your device cleared on March 16, 2020. Specifically, FDA is updating this SE Letter due to the clearance date not appearing on the original letter.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Assistant Director, Neil Ogden, at 301-796-6397 or [e-mail].

> Sincerely Digitally signed by Neil R.P. Ogden Date: 2021.05.26 16:04:49 -04'00' Neil R.P. Ogden 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

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Image /page/1/Picture/0 description: The image contains 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" on one line and "ADMINISTRATION" on the line below.

WON TECH Co., Ltd. Lana Hong Staff of Regulatory Affairs 64 Techno 8-Ro. Yuseong-gu Daejeon, 34028 Kr

Re: K200110

Trade/Device Name: SANDRO Dual 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: January 13, 2020 Received: January 17, 2020

Dear Lana Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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

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801 and Part 809); 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 (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Jessica Mavadia-shukla -S

Jessica Mavadia-Shukla, Ph.D. 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) K200110

Device Name SANDRO Dual

Indications for Use (Describe)

The SANDRO Dual Laser System is indicated for the following at the specified wavelength:

755nm

Temporary hair reduction. Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is defined as the long-term. stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I-VI) including tanned skin.

Treatment of benign pigmented lesions.

Treatment of wrinkles.

The photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas)

1064nm

Removal of unwanted hair, for stable long term or permanent hair reduction. Permanent hair reduction is defined as the long-term. stable reduction in the number of hairs regrowing when measured at 6. 9. and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Benign pigmented and/or benign vascular lesions, such as, but not limited to port-wine stains, telangiectasia, venus and spider veins. Benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, skin tags, keratosis.

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.

Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

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/4/Picture/1 description: The image shows the logo for WONTECH. The logo features a stylized "W" in orange, followed by the text "WON" in red and "TECH" in gray. The "W" is made up of curved lines that intersect to form the shape of the letter.

64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea, 34028 Tel: [phone] / Fax: [phone]

## Section 5. 510(k) Summary

## 510(k) Summary

[As required by 21 CFR 807.92]

#### 1. Date Prepared [21 CFR 807.92(a)(a)]

January 13, 2020

#### 2. Submitter's Information [21 CFR 807.92(a)(1)]

- Name of company WON TECH Co., Ltd.
- Address: 64 Techno 8-Ro, Yuseong-gu, Daejeon, Republic of Korea, 34028 ●
- Contact Name: Lana Hong/ Staff of Regulatory Affair ●
- [phone] Telephone No.: ●
- Fax No.: [phone] ●
- Email Address: ● [e-mail]

#### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)|

| Trade Name | SANDRO Dual |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Common Name | Dermatology Laser System |
| Device Classification Name | Laser surgical instrument for use in general and plastic surgery and in<br>dermatology (21 CFR 878.4810, Product Code GEX) |
| Regulation Number | 21 CFR 878.4810 |
| Classification Product Code | GEX |
| Device Class | Class II |
| 510k Review Panel | General & Plastic Surgery |

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Image /page/5/Picture/1 description: The image shows the logo for WONTECH. The logo consists of a stylized letter "W" in orange and yellow gradient, followed by the text "WONTECH" in red and gray. The "WON" part of the text is in red, while the "TECH" part is in gray.

64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea, 34028 Tel: [phone] / Fax: [phone]

#### Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[ 4.

The identified predicate device within this submission are shown as follow:

| • | 510(k) Number: | K140122 |
|---|----------------------|------------------------------------------------------------------------------------------------------------------------------|
| • | Applicant: | Candela Corporation |
| • | Classification Name: | Laser surgical instrument for use in general<br>and plastic surgery and in dermatology<br>(21 CFR878.4810, Product Code GEX) |
| • | Trade Name: | GentleMAX Family of Laser Systems |

#### ર. Description of the Device [21 CFR 807.92(a)(4)]

The SANDRO Dual is a Nd:YAG and Alexandrite laser operating at wavelengths of 1,064 nm and 755 nm. The SANDRO Dual consists of the main body, optical fiber cable, handpiece tip, footswitch, and handbiece cable holder. The laser output is delivered to the optical fiber terminated by the handbiece. The SANDRO Dual laser system is used for a variety of medical purpose such as an ablation. incision and removal of targeted tissue. For treatment, the user can select the appropriate fluence value. The energy is changed automatically in accordance with the selected fluence value and selected spot size. The user can change the fluence value by pressing UP and/or DOWN button from the LCD display/Touch Pad located on the front of the main unit.

#### 6. Indications for Use [21 CFR 807.92(a)(5)]

The SANDRO Dual Laser System is indicated for the following at the specified wavelength:

### 755nm

Temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin.

Treatment of benign pigmented lesions.

Treatment of wrinkles.

The photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias)

### 1064nm

Removal of unwanted hair, for stable long term or permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after

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Image /page/6/Picture/1 description: The image shows the logo for WONTECH. The logo consists of a stylized letter "W" in orange and yellow, followed by the word "WON" in red and "TECH" in gray. The logo is simple and modern, and the colors are bright and eye-catching.

64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea, 34028 Tel: [phone] / Fax: [phone]

the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Benign pigmented and/or benign vascular lesions, such as, but not limited to port-wine stains, telangiectasia, venus lake, leg veins and spider veins. Benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, skin tags, keratosis.

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.

Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

#### Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)] 7.

There are no significant differences in the technological characteristics of this device compared to the predicate device which adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the SANDRO Dual and the predicate devices:

| | Proposed Device | Predicate Device | SE decision |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| K Number | K200110 | K140122 | - |
| Manufacturer | WON TECH Co., Ltd. | Candela Corporation | - |
| Model | SANDRO Dual | GentleMAX Family of Laser Systems | - |
| Product Code | GEX | GEX | Same |
| Indications for Use | The SANDRO Dual Laser System is indicated for the following at the specified wavelength:<br><br>755nm<br>Temporary hair reduction.<br>Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. | The GentleMAX Family of Laser Systems is indicated for the following at the specified wavelength:<br><br>755nm<br>Temporary hair reduction.<br>Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types | Same |
| Proposed Device | Predicate Device | SE decision | |
| Treatment of benign<br>pigmented lesions.<br>Treatment of wrinkles.<br>The photocoagulation of<br>dermatological benign<br>vascular lesions (such as port-wine stains, hemangiomas, telangiectasias) | (Fitzpatrick [- VI) including<br>tanned skin. | | |
| 1064nm<br>Removal of unwanted hair, for<br>stable long term or permanent<br>hair reduction. Permanent hair<br>reduction is defined as the<br>long-term, stable reduction in<br>the number of hairs regrowing<br>when measured at 6, 9, and 12<br>months after the completion of<br>a treatment regime. The lasers<br>are indicated on all skin types<br>Fitzpatrick I-VI including<br>tanned skin. Benign<br>pigmented and/or benign<br>vascular lesions, such as, but<br>not limited to port-wine stains,<br>telangiectasia, venus lake, leg<br>veins and spider veins. Benign<br>pigmented lesions such as, but<br>not limited to lentigos (age<br>spots), solar lentigos (sun<br>spots), cafe au lait macules,<br>seborrheic keratosis, nevi,<br>chloasma, skin tags, keratosis.<br>Reduction of red pigmentation<br>in hypertrophic and keloid<br>scars where vascularity is an<br>integral part of the scar.<br>Treatment of wrinkles.<br>Temporary increase of clear<br>nail in patients with<br>onychomycosis (e.g.,<br>dermatophytes, Trichophyton<br>rubrum and T.<br>mentagrophytes, and/or yeast<br>Candida Albicans, etc.) | 1064nm<br>Removal of unwanted hair,<br>for stable long term or<br>permanent hair reduction and<br>for treatment of PFB.<br>Permanent hair reduction is<br>defined as the long-term,<br>stable reduction in the<br>number of hairs regrowing<br>when measured at 6, 9, and<br>12 months after the<br>completion of a treatment<br>regime. The lasers are<br>indicated on all skin types<br>Fitzpatrick I-VI including<br>tanned skin.<br>Photocoagulation and<br>hemostasis of pigmented and<br>vascular lesions such as but<br>not limited to port wine<br>stains, hemangioma, warts,<br>telangiectasia, rosacea, venus<br>lake, leg veins and spider<br>veins. Coagulation and<br>hemostasis of soft tissue.<br>Benign pigmented lesions<br>such as, but not limited to,<br>lentigos (age spots), solar<br>lentigos (sun spots), cafe au<br>lait macules, seborrheic<br>keratosis, nevi, chloasma,<br>verrucae, skin tags, keratosis,<br>tattoos (significant reduction<br>in the intensity of black | | |
| | Proposed Device | Predicate Device | SE decision |
| | | and/or blue-black tattoos) and<br>plaques. | |
| | | The laser is indicated for<br>pigmented lesions to reduce<br>lesion size, for patients with<br>lesions that would potentially<br>benefit from aggressive<br>treatment, and for patients<br>with lesions that have not<br>responded to other laser<br>treatments. | |
| | | Reduction of red<br>pigmentation in hypertrophic<br>and keloid scars where<br>vascularity is an integral part<br>of the scar.<br>Treatment of wrinkles. | |
| | | 1064nm<br>Temporary increase of clear<br>nail in patients with<br>onychomycosis (e.g.,<br>dermatophytes, Trichophyton<br>rubrum and T.<br>mentagrophytes, and/or yeast<br>Candida Albicans, etc.) | |
| Laser Type | Flash lamp-excited, Solid state<br>Alexandrite and Nd:YAG<br>laser | Flash lamp-excited, Solid<br>state Alexandrite and<br>Nd:YAG laser | Same |
| Wavelength | 755nm / 1064nm | 755nm / 1064nm | Same |
| Laser Output | 755nm: Max. 50J<br>1064nm: Max. 80J | 755nm: Max. 50J<br>1064nm: Max. 80J | Same |
| Spot Size | 2, 3, 5, 7, 10, 12, 15, 18,<br>20mm | 1.5, 3, 6, 8, 10, 12, 15, 18<br>mm | No new issues on<br>safety and<br>effectiveness |
| Pulse Duration | 0.3ms - 100ms | 0.25ms - 100ms | Same |
| Repetition Rate | 0.5 ~ 10Hz | Max. 10Hz | Same |
| Aiming Beam | 532 nm, 5mW(Average) | 520 nm to 550 nm, less than<br>8 mW | No other issue of<br>safety and<br>effectiveness<br>because the Energy<br>output delivered to<br>the patient is at the |
| | Proposed Device | Predicate Device | SE decision…