(263 days)
No
The 510(k) summary describes a laser system for skin resurfacing. The description focuses on the hardware components, laser technology, and standard software controls. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies for analysis, treatment planning, or outcome prediction. The performance studies described are standard for laser devices and do not involve AI/ML model validation.
Yes
The device is intended for "General skin resurfacing procedures" and "Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars)", which are therapeutic applications.
No
The device description and intended use indicate it is an aesthetic and surgical laser system for skin resurfacing and treating various skin conditions, not for diagnosing them. It delivers laser energy for treatment purposes.
No
The device description explicitly details numerous hardware components including a laser module, power supply, scanner drivers, TEC cooling module, water pump, fans, and a handpiece for energy delivery. This is a physical laser system, not a software-only device.
Based on the provided information, the UltraClear Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "General skin resurfacing procedures" and various fractional applications on the skin. This is a therapeutic use, directly treating the patient's skin.
- Device Description: The device is a laser system that delivers energy to the skin. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is to alter the skin tissue.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The UltraClear Laser System does not fit this description.
N/A
Intended Use / 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).
Product codes
GEX, ONG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dermatology and Plastic Surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Joule ProFractional System (K180508)
Reference Device(s)
CO2RE System (K181523)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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
2
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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3
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, LP
614 George Washington Highway
Lincoln, RI 02865
(619) 988-4796 | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Official Correspondent | Sharon Timberlake Consulting, LLC
Sharon Timberlake, MSHS, RAC, CCRA
27 Dunelm Road
Bedford, 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 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. | |
| 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). | |
4
Predicate Comparison Table
| 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 |
5
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.
6
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.