(263 days)
The UltraClear Laser System is intended for use in Dermatology and Plastic Surgery applications for the following indications for use: General skin resurfacing procedures. Ultra mode is further indicated for the following fractional applications: Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).
UltraClear Laser System is a transportable device. The system includes the 15" touch screen, on/off switch, foot peddle, an emergency stop button, remote interlock, and calibration port. The device console houses most of the power consuming components, including the laser module, medical grade power supply, the scanner drivers, software, TEC cooling module, water pump, fans, software controls, and all other electrical control components. The laser system is a fiber laser device operating at a wavelength of 2,910nm. The system incorporates a fiber couple laser diode assembly pumping erbium doped fluoride glass fiber to generate laser emission. The laser energy is delivered during treatment via the handpiece. A 635 nm visible red laser diode aiming beam is used to visualize the location of the beam during laser treatment.
The provided text describes a 510(k) premarket notification for the UltraClear Laser System, a medical device for dermatological and plastic surgery applications. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of an AI/ML study.
Therefore, most of the information requested in your prompt (e.g., acceptance criteria for AI performance, sample size for test sets, number of experts for ground truth, MRMC studies, standalone AI performance) is not present in the provided document, as it pertains to the clearance of a laser system, not an AI/ML-based device.
Here's an analysis based on the information that is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria in a structured table format for performance metrics in the way one would for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, it relies on demonstrating substantial equivalence to a predicate device through a comparison of technical specifications and performance studies validating the laser's physical characteristics and safety.
The "Predicate Comparison Table" (Page 4) effectively serves as a comparison of specifications against a "substantial equivalence assessment." The acceptance criteria here are implicitly that the UltraClear Laser System's specifications are "Same," "Similar, within range," or "Substantially equivalent" to the predicate device.
| Specifications | UltraClear Fractional Laser System | JOULE ProFractional System | Substantial Equivalence Assessment |
|---|---|---|---|
| Manufacturer | FA International | Sciton, Inc. | Not Applicable |
| K Number | K210847 | K180508 | Not Applicable |
| Product Code | GEX, ONG | GEX, ONG | Same |
| Prescription Use | Yes | Yes | Same |
| Laser Energy Source | Er: YAG | Er: YAG | Same |
| Laser Delivery | Fiber & Handpiece | Fiber, Handpiece, Articulated arm | Substantially equivalent |
| Wavelength | 2910 nm | 2940 nm | Substantially equivalent |
| Aiming Beam | Red diode laser 5mW | Red diode laser 5mW | Same |
| Target Chromophore | Water | Water | Same |
| Fractional Technology | Yes | Yes | Same |
| Energy per Microbeam(mJ/mb) | 0.6-1.5 (Clear Mode), 1.5-3.0 (Silk Mode), 3.6-35.0 (Ultra Mode), 0.6-1.5, 3.6-35.0 (UltraClear-Mode) | Up to 70 | Similar, within range |
| Adjustable Spot Size | 2x2mm - 15x15mm | 1.3x1.3mm - 20x20mm | Substantially equivalent |
| Pulse/Repetition Rate | Up to 3 Hz | Up to 3 Hz | Same |
| Pulse Width/Duration | 0.1 to 3.0 msec (or 3000 usec) | 0.5 to 1.5 msec (or 1500 usec) | Substantially equivalent |
| Delivery System | Fiber optic arm with handpiece | Articulated arm and/or fiber optic arm with handpiece | Same |
| Cooling System | Water & Air | Water & Air | Same |
| Electrical Requirements | 100-240 VAC/8.5A, 50/60 Hz | 230 VAC/25A, 50/60 Hz | Substantially equivalent |
| Software/GUI/Touch Screen | Yes | Yes | Same |
| Energy Monitor | Display Indicates Energy Delivered to Tissue | Display Indicates Energy Delivered to Tissue | Same |
| Console Dimensions | w15.9" x d20.5" x h42.1" | w14" x d21" x h41" | Substantially equivalent |
| Weight | 80 Lbs | 200 Lbs | Substantially equivalent |
| Power Supply | Yes | Yes | Same |
The performance data mentioned in the document primarily relates to:
- Histology Study: "Human biopsies were taken and analyzed post laser treatment. Tissue samples were taken from three participants to establish the thermal damage and tissue effect of lasing." (Page 5) The specific "performance" results (e.g., degree of thermal damage, specific tissue effects) are not quantified or provided in this summary, but the study was conducted to confirm the expected effects.
- Biocompatibility: "The patient contacting material of the handpiece are identical to the reference device." (Page 5) This means the biocompatibility is implicitly accepted as equivalent to the predicate device.
- Electromagnetic Compatibility & Electrical Safety: "UltraClear Laser System underwent electrical safety and electromagnetic compatibility with passing results according to the following recognized standards." (Page 6) This indicates compliance with established safety standards.
- Software Validation and Verification Testing: "UltraClear Laser System underwent software verification and validation testing, which demonstrated the software is appropriate for release and that the system performed as intended. Furthermore, the testing verified the energy outputs of the system meet its design specifications." (Page 6) The performance is stated as "performed as intended" and "meet its design specifications," but no specific quantitative metrics or acceptance criteria for software performance are detailed.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: For the histology study, "Tissue samples were taken from three participants." (Page 5). This is the only explicit "test set" mentioned.
- Data Provenance: The document does not specify the country of origin for the human biopsies. It does not mention if the data was retrospective or prospective, though the description implies prospective collection for the histology study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of this device and study. The "ground truth" for the histology study would be established by standard pathological analysis, but the number or qualifications of experts are not specified.
4. Adjudication method for the test set
Not applicable in the context of this device and study.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-based device.
7. The type of ground truth used
For the histology study, the ground truth was derived from "human biopsies" and "thermal damage and tissue effect of lasing" (pathology/tissue effects).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The device is a physical laser system.
9. How the ground truth for the training set was established
Not applicable.
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December 10, 2021
FA International, LP % Sharon Timberlake Regulatory Consultant Sharon Timberlake Consulting, LLC 27 Dunelm Road Bedford, Massachusetts 01730
Re: K210847
Trade/Device Name: UltraClear Laser System 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, ONG Dated: May 9, 2021 Received: May 11, 2021
Dear Sharon Timberlake:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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-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 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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.
Purva Pandya 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)
Device Name UltraClear Laser System
Indications for Use (Describe)
The UltraClear Laser System is intended for use in Dermatology and Plastic Surgery applications for the following indications for use:
General skin resurfacing procedures
Ultra mode is further indicated for the following fractions: Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).
| 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) |
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K210847
510(k) Summary
UltraClear Laser System
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
| Owner/Applicant: | FA International, LP614 George Washington HighwayLincoln, RI 02865(619) 988-4796 | |
|---|---|---|
| Official Correspondent | Sharon Timberlake Consulting, LLCSharon Timberlake, MSHS, RAC, CCRA27 Dunelm RoadBedford, MA 01730(617) 957-1434 | |
| Date of Summary: | December 8, 2021 | |
| Device Trade Name: | UltraClear Laser System | |
| Common/Usual Name: | 2910 nm laser system | |
| Regulation Number: | 21 CFR 878.4810 | |
| Device Class: | II | |
| Product Code: | GEX/ONG | |
| Panel: | General and Plastic Surgery | |
| Predicate Devices | Joule ProFractional System (K180508) | |
| Reference Device | CO2RE System (K181523) | |
| Device Description: | UltraClear Laser System is a transportable device. The systemincludes the 15" touch screen, on/off switch, foot peddle, anemergency stop button, remote interlock, and calibration port.The device console houses most of the power consumingcomponents, including the laser module, medical grade powersupply, the scanner drivers, software, TEC cooling module, waterpump, fans, software controls, and all other electrical controlcomponents.The laser system is a fiber laser device operating at a wavelength of2,910nm. The system incorporates a fiber couple laser diodeassembly pumping erbium doped fluoride glass fiber to generatelaser emission. The laser energy is delivered during treatment viathe handpiece. A 635 nm visible red laser diode aiming beam isused to visualize the location of the beam during laser treatment. | |
| Indications for Use: | The UltraClear Laser System is intended for use in Dermatology and Plastic Surgery applications for the following indications for use: General skin resurfacing procedures. Ultra mode is further indicated for the following fractional applications: Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars). |
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Predicate Comparison Table
| Specifications | UltraClearFractional LaserSystem | JOULE ProFractionalSystem | SubstantialEquivalenceAssessment |
|---|---|---|---|
| Manufacturer | FA International | Sciton, Inc. | Not Applicable |
| K Number | K210847 | K180508 | Not Applicable |
| Product Code | GEX, ONG | GEX, ONG | Same |
| Prescription Use | Yes | Yes | Same |
| Laser Energy Source | Er: YAG | Er: YAG | Same |
| Laser Delivery | Fiber & Handpiece | Fiber, Handpiece,Articulated arm | Substantiallyequivalent |
| Wavelength | 2910 nm | 2940 nm | Substantiallyequivalent |
| Aiming Beam | Red diode laser5mW | Red diode laser5mW | Same |
| TargetChromophore | Water | Water | Same |
| FractionalTechnology | Yes | Yes | Same |
| Energy perMicrobeam(mJ/mb) | 0.6-1.5 (Clear Mode)1.5-3.0 (Silk Mode)3.6-35.0 (Ultra Mode)0.6-1.5, 3.6-35.0(UltraClear-Mode) | Up to 70 | Similar, withinrange |
| AdjustableSpot Size | 2x2mm - 15x15mm | 1.3x1.3mm - 20x20mm | Substantiallyequivalent |
| Pulse/RepetitionRate | Up to 3 Hz | Up to 3 Hz | Same |
| PulseWidth/Duration | 0.1 to 3.0 msec (or3000 usec) | 0.5 to 1.5 msec (or1500 usec) | Substantiallyequivalent |
| Delivery System | Fiber optic arm withhandpiece | Articulated arm and/orfiber optic arm withhandpiece | Same |
| Cooling System | Water & Air | Water & Air | Same |
| ElectricalRequirements | 100-240 VAC/8.5A,50/60 Hz | 230 VAC/25A, 50/60Hz | Substantiallyequivalent |
| Software/GUI/Touch Screen | Yes | Yes | Same |
| Energy Monitor | Display IndicatesEnergy Delivered toTissue | Display IndicatesEnergy Delivered toTissue | Same |
| Console Dimensions | w15.9" x d20.5" xh42.1" | w14" x d21" x h41" | Substantiallyequivalent |
| Weight | 80 Lbs | 200 Lbs | Substantiallyequivalent |
| Power Supply | Yes | Yes | Same |
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Technological Characteristics / Substantial Equivalence
The UltraClear Laser System is substantially equivalent in design, function, operating principles, and intended use to the Joule ProFractional System (K180508) predicate device based on the information presented. The devices share the same design and technical features, which includes calibration port, handpiece, similar wavelength, laser medium, fiber delivery, power supply, internal cooling system, hardware, electronics, firmware, software and user display screen.
Both the new device and predicate device share the same laser operating principles, such as energy, pulse width, repetition rate, energy delivery and offers a range of spot sizes. Any minor design differences do not raise any new types of safety or effectiveness questions, thus rendering substantial equivalence.
Performance Data
FA International, LP conducted performance studies to confirm the overall functional specification testing of the UltraClear Laser System against its design specifications and intended use. The following testing was conducted in support substantial equivalence.
Histology Study
Human biopsies were taken and analyzed post laser treatment. Tissue samples were taken from three participants to establish the thermal damage and tissue effect of lasing.
Biocompatibility
The patient contacting material of the handpiece are identical to the reference device.
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Electromagnetic Compatibility & Electrical Safety
UltraClear Laser System underwent electrical safety and electromagnetic compatibility with passing results according to the following recognized standards.
- IEC 60825-1, 2007: Safety of Laser Products – Part 1: Equipment classification and requirements.
- IEC 60601-1, 2005+A1:2012: Medical electrical equipment-- Part 1: General ● requirements for basic safety and essential performance.
- IEC 60601-1-2 Edition 4.0 2014-02: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-2-22:2007 + A1: 2012, Edition 3.1: Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
Software Validation and Verification Testing
UltraClear Laser System underwent software verification and validation testing, which demonstrated the software is appropriate for release and that the system performed as intended. Furthermore, the testing verified the energy outputs of the system meet its design specifications.
Conclusion
The UltraClear Laser System has the same Intended Use/Indications for Use as the predicate device. The minor differences between the two devices do not raise new or different questions about safety and effectiveness. The performance data presented in this 510(k) Premarket Notification support the safety of the new device. Additionally, the data further supports the new device should perform as intended and to its specifications. In sum, the UltraClear Laser System is as safe and effective as its predicate device.
§ 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.