(59 days)
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.)
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.
The provided document is a 510(k) summary for the WON TECH Co., Ltd. SANDRO Dual laser system. It outlines the device's characteristics and its substantial equivalence to a predicate device (Candela Corporation's GentleMAX Family of Laser Systems).
Based on the content, here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics for a diagnostic device. Instead, it demonstrates "substantial equivalence" to a predicate device (GentleMAX Family of Laser Systems) by comparing technical specifications for safety and effectiveness. The "reported device performance" is essentially a comparison of these technical specifications.
| Feature | SANDRO Dual (Proposed Device) | GentleMAX Family of Laser Systems (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 | Shared between devices (see detailed breakdown below) | Shared between devices (see detailed breakdown below) | Same |
| Laser Type | Flash lamp-excited, Solid state Alexandrite and Nd:YAG laser | Flash lamp-excited, Solid state Alexandrite and Nd:YAG laser | Same |
| Wavelength | 755nm / 1064nm | 755nm / 1064nm | Same |
| Laser Output | 755nm: Max. 50J; 1064nm: Max. 80J | 755nm: Max. 50J; 1064nm: Max. 80J | Same |
| Spot Size | 2, 3, 5, 7, 10, 12, 15, 18, 20mm | 1.5, 3, 6, 8, 10, 12, 15, 18 mm | No new issues on safety and effectiveness (due to comparable wavelength, repetition rate, and energy output). |
| 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 8 mW | No other issue of safety and effectiveness (due to comparable energy output). |
| Electrical Consumption | 220-230V~, 50/60Hz, Single phase | 200-240V~, 50/60 Hz, single phase | Same |
| Pulse Control Method | Footswitch | Footswitch | Same |
| Skin Cooling Method | SCS: Skin Cooling Spray | DCD: Dynamic Cooling Device | No new issues on safety and effectiveness. |
| Dimensions (W x L x H) | 460 mm × 978 mm × 1110 mm | 42"x 18" x 27" (1067 x 457 x 686 mm) | No new issues on safety and effectiveness. |
| Weight | 110 kg | 260 lbs (118 kg) | No new issues on safety and effectiveness. |
Detailed Indications for Use Comparison:
The "Indications for Use" for both the SANDRO Dual and the predicate device are largely identical, covering:
- 755nm: Temporary hair reduction, stable long-term or permanent hair reduction (at 6, 9, 12 months post-treatment on all skin types I-VI, including tanned skin), treatment of benign pigmented lesions, treatment of wrinkles, and photocoagulation of dermatological benign vascular lesions (port-wine stains, hemangiomas, telangiectasias).
- 1064nm: Removal of unwanted hair, stable long-term or permanent hair reduction (at 6, 9, 12 months post-treatment on all skin types I-VI, including tanned skin), benign pigmented and/or benign vascular lesions (e.g., port-wine stains, telangiectasia, venus lake, leg and spider veins), benign pigmented lesions (e.g., lentigos, solar lentigos, cafe au lait macules, seborrheic keratosis, nevi, chloasma, skin tags, keratosis), reduction of red pigmentation in hypertrophic and keloid scars (where vascularity is integral), treatment of wrinkles, and temporary increase of clear nail in patients with onychomycosis.
The predicate device also listed "treatment of PFB" for 1064nm hair reduction and "Coagulation and hemostasis of soft tissue" and "tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques" for 1064nm indications, which are not explicitly mentioned for the SANDRO Dual. However, the FDA deemed them "Same" or noted "No new issues on safety and effectiveness."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical studies were considered necessary and performed."
Therefore, there is no test set, sample size, or data provenance from clinical studies as this clearance relies on substantial equivalence to a predicate device and non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical studies were performed, and thus no test set with expert-established ground truth was used for performance validation in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies were performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a laser surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser surgical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not explicitly applicable in the context of clinical performance evaluation (since no clinical studies were performed). For the purpose of establishing substantial equivalence, the "ground truth" relies on:
- Technical specifications and comparisons to the predicate device.
- Compliance with international standards:
- ES60601-1 (AAMI): Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance
- 60601-1-2 (IEC): Electromagnetic Compatibility
- 60601-2-22 (IEC): Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment
- 60825-1 (IEC): Safety of Laser Products
- Software validation: The software for the SANDRO Dual was designed and developed according to a software development process and was verified and validated as a Moderate level of concern software.
- Biocompatibility testing: Performed according to ISO 10993-1 and FDA Blue Book Memo #G95-1 (Cytotoxicity, Intracutaneous reactivity, Skin sensitization).
8. The sample size for the training set
Not applicable. This device is a laser surgical instrument, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a laser surgical instrument.
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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 neil.ogden@fda.hhs.gov.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: +82-70-7836-6921 / Fax: +82-70-934-9491
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 ●
- +82-70-7836-6970 Telephone No.: ●
- Fax No.: +82-70-934-9491 ●
- Email Address: ● regulatory@wtlaser.com
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 indermatology (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: +82-70-7836-6921 / Fax: +82-70-934-9491
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 generaland plastic surgery and in dermatology(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: +82-70-7836-6921 / Fax: +82-70-934-9491
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:755nmTemporary 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. | The GentleMAX Family of Laser Systems is indicated for the following at the specified wavelength:755nmTemporary 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 | Same |
| Proposed Device | Predicate Device | SE decision | |
| Treatment of benignpigmented lesions.Treatment of wrinkles.The photocoagulation ofdermatological benignvascular lesions (such as port-wine stains, hemangiomas, telangiectasias) | (Fitzpatrick [- VI) includingtanned skin. | ||
| 1064nmRemoval of unwanted hair, forstable long term or permanenthair reduction. Permanent hairreduction is defined as thelong-term, stable reduction inthe number of hairs regrowingwhen measured at 6, 9, and 12months after the completion ofa treatment regime. The lasersare indicated on all skin typesFitzpatrick I-VI includingtanned skin. Benignpigmented and/or benignvascular lesions, such as, butnot limited to port-wine stains,telangiectasia, venus lake, legveins and spider veins. Benignpigmented lesions such as, butnot limited to lentigos (agespots), solar lentigos (sunspots), cafe au lait macules,seborrheic keratosis, nevi,chloasma, skin tags, keratosis.Reduction of red pigmentationin hypertrophic and keloidscars where vascularity is anintegral part of the scar.Treatment of wrinkles.Temporary increase of clearnail in patients withonychomycosis (e.g.,dermatophytes, Trichophytonrubrum and T.mentagrophytes, and/or yeastCandida Albicans, etc.) | 1064nmRemoval of unwanted hair,for stable long term orpermanent hair reduction andfor treatment of PFB.Permanent hair reduction isdefined as the long-term,stable reduction in thenumber of hairs regrowingwhen measured at 6, 9, and12 months after thecompletion of a treatmentregime. The lasers areindicated on all skin typesFitzpatrick I-VI includingtanned skin.Photocoagulation andhemostasis of pigmented andvascular lesions such as butnot limited to port winestains, hemangioma, warts,telangiectasia, rosacea, venuslake, leg veins and spiderveins. Coagulation andhemostasis of soft tissue.Benign pigmented lesionssuch as, but not limited to,lentigos (age spots), solarlentigos (sun spots), cafe aulait macules, seborrheickeratosis, nevi, chloasma,verrucae, skin tags, keratosis,tattoos (significant reductionin the intensity of black | ||
| Proposed Device | Predicate Device | SE decision | |
| and/or blue-black tattoos) andplaques. | |||
| The laser is indicated forpigmented lesions to reducelesion size, for patients withlesions that would potentiallybenefit from aggressivetreatment, and for patientswith lesions that have notresponded to other lasertreatments. | |||
| Reduction of redpigmentation in hypertrophicand keloid scars wherevascularity is an integral partof the scar.Treatment of wrinkles. | |||
| 1064nmTemporary increase of clearnail in patients withonychomycosis (e.g.,dermatophytes, Trichophytonrubrum and T.mentagrophytes, and/or yeastCandida Albicans, etc.) | |||
| Laser Type | Flash lamp-excited, Solid stateAlexandrite and Nd:YAGlaser | Flash lamp-excited, Solidstate Alexandrite andNd:YAG laser | Same |
| Wavelength | 755nm / 1064nm | 755nm / 1064nm | Same |
| Laser Output | 755nm: Max. 50J1064nm: Max. 80J | 755nm: Max. 50J1064nm: Max. 80J | Same |
| Spot Size | 2, 3, 5, 7, 10, 12, 15, 18,20mm | 1.5, 3, 6, 8, 10, 12, 15, 18mm | No new issues onsafety andeffectiveness |
| 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 than8 mW | No other issue ofsafety andeffectivenessbecause the Energyoutput delivered tothe patient is at the |
| Proposed Device | Predicate Device | SE decision | |
| same levelcompared to thesame. | |||
| Electricalconsumption | 220-230V~, 50/60Hz, Singlephase | 200-240V~, 50/60 Hz, singlephase | Same |
| Pulse controlmethod | Footswitch | Footswitch | Same |
| Skin coolingmethod | SCS: Skin Cooling Spray | DCD: Dynamic CoolingDevice | No new issues onsafety andeffectiveness |
| Dimensions(W x L x H) | 460 mm × 978 mm × 1110mm | 42"x 18" x 27" (inch)(1067 x 457 x 686 mm) | No new issues onsafety andeffectiveness |
| Weight | 110 kg | 260 lbs(118 kg) | No new issues onsafety andeffectiveness |
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Image /page/7/Picture/1 description: The image contains the logo for WONTECH. The logo features a stylized "W" symbol in orange and yellow, followed by the text "WON" in red and "TECH" in gray. The logo is simple and modern, with a focus on the company name.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea, 34028 Tel: +82-70-7836-6921 / Fax: +82-70-934-9491
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Image /page/8/Picture/1 description: The image shows the logo for WONTECH. The logo consists of a stylized letter "W" inside of an orange circle. To the right of the circle is the text "WONTECH" with "WON" in red and "TECH" in gray.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea, 34028 Tel: +82-70-7836-6921 / Fax: +82-70-934-9491
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Image /page/9/Picture/0 description: The image shows the logo for WONTECH. The logo features a stylized "W" symbol in orange and yellow gradient, followed by the text "WON" in red and "TECH" in gray. The text is in a bold, sans-serif font.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea, 34028 Tel: +82-70-7836-6921 / Fax: +82-70-934-9491
The difference in maximum spot size does not raise any new safety and effectiveness issues the SANDRO Dual has the same wavelength, repetition rate and energy output delivered to the patient are at the same level compared to the predicate device. The differences between SANDRO Dual and the predicate device in regard to skin cooling method, weight and dimensions do not raise any new safety and effectiveness issues.
Verification and validation activities were conducted to establish the performance and safety characteristics of the SANDRO Dual. The results of these activities show that there are no any new safety and effectiveness issues. Therefore, the SANDRO Dual is considered substantially equivalent to the predicate device.
Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
- Electrical Safety, Electromagnetic Compatibility and Performance.
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
| StandardsNo. | StandardsOrganization | Standard Title | Version | PublicationYear |
|---|---|---|---|---|
| ES60601-1 | AAMI | Medical Electrical Equipment - Part 1: GeneralRequirements for Basic Safety and Essential Performance | Edition 3.1 | 2016 |
| 60601-1-2 | IEC | Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety - Collateral Standard:Electromagnetic Compatibility - Requirements and Tests | Edition 4 | 2018 |
| 60601-2-22 | IEC | Medical Electrical Equipment - Part 2-22: ParticularRequirements for Basic Safety and Essential Performanceof Surgical, Cosmetic, Therapeutic and Diagnostic LaserEquipment | Edition 3 | 2019 |
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Image /page/10/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a white "W" inside of it. To the right of the circle, the word "WONTECH" is written in red and gray letters. The word "WON" is in red, and the word "TECH" is in gray.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea, 34028 Tel: +82-70-7836-6921 / Fax: +82-70-934-9491
| StandardsNo. | StandardsOrganization | Standard Title | Version | PublicationYear |
|---|---|---|---|---|
| 60825-1 | IEC | Safety of Laser Products - Part 1: EquipmentClassification, and Requirements | Edition 3 | 2019 |
2) Software Validation
The SANDRO Dual contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated.
The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.
3) Biocompatibility
According to the recommendations of ISO 10993-1 and FDA Blue Book Memo #G95-1, the following tests were performed:
- Cytotoxicity test according to ISO 10993-5:2009 -
- -Intracutaneous (intradermal) reactivity test according to ISO 10993-10:2010
- Skin sensitization test according to ISO 10993-10:2010 -
Clinical Test Summary [21 CFR 807.92(b)(2)]
No clinical studies were considered necessary and performed.
8. Conclusion [21 CFR 807.92(b)(3)]
The SANDRO Dual has the same intended uses, utilize similar operating principles, and match key design aspects. including similar spot size, the same wavelengths and the variable delivered fluence in comparison to the predicate device. On the basis of similarities in method of operation, intended uses, and key technical characteristics. WON TECH Co., Ltd., believes that the SANDRO Dual is substantially equivalent to the predicate device. In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification WON TECH Co., Ltd., concludes that the SANDRO Dual is substantially equivalent in safety and effectiveness to the predicate device as described herein.
§ 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.