(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.
§ 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.