(161 days)
Joule Profractional System K173285
UltraClear Fractional Laser System K210847
No
The summary describes a laser system for dermatological procedures and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
The device is described as "intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue" for various medical conditions, which clearly indicates a therapeutic purpose.
No.
The device description and intended use indicate that the UltraClear Fractional Laser System is for therapeutic dermatological procedures (e.g., coagulation, resurfacing, ablation of soft tissue, treatment of wrinkles, scars). There is no mention of it being used to diagnose conditions or provide diagnostic information.
No
The device description explicitly details numerous hardware components, including a touch screen, foot pedal, laser module, power supply, scanner drivers, and a handpiece for energy delivery. The performance studies also include testing related to hardware, such as biocompatibility and electrical safety.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue." This involves direct interaction with the patient's body for treatment purposes.
- Device Description: The description details a laser system that delivers energy to the skin via a handpiece. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition. IVDs are designed to perform tests on samples taken from the body to diagnose diseases or conditions.
- Anatomical Site: The device is used on "soft tissue (dermatological procedures)," which is a direct application to the patient's body, not the analysis of a sample.
In summary, the UltraClear Fractional Laser System is a therapeutic device used for treating skin conditions, not a diagnostic device used for analyzing samples to provide diagnostic information.
N/A
Intended Use / Indications for Use
The UltraClear Fractional Laser System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytids, furrows, fine lines, textural irregularites, epider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), benign pigmented lesions, and vascular dyschromia.
Fractional Effects:
The UltraClear Fractional Laser System with its accessories when used in intended to produce fractional effects during skin resurfacing
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
UltraClear Fractional 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 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Acclaro Corporation conducted non-clinical performance studies to confirm the overall functional specification testing of the UltraClear Fractional Laser System against its design specifications and intended use.
The following testing was conducted in support substantial equivalence.
Biocompatibility Testing
Testing was conducted in accordance with ISO-10993-1 to demonstrate the patient contacting material of the handpiece is safe for transient use (≤24 hours of contacting).
Electromagnetic Compatibility & Electrical Safety
UltraClear Fractional 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 Ed. 3, 2007-03: 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 Third Edition, 2007-05: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
UltraClear Fractional 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Joule Profractional System K173285
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
UltraClear Fractional Laser System K210847
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Acclaro Corporation Shlomo Assa President 333 George Washington Highway Smithfield. Rhode Island 02865
Re: K233803
Trade/Device Name: UltraClear Fractional 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 Dated: November 29, 2023 Received: November 29, 2023
Dear Shlomo Assa:
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 (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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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,
Tanisha L. Digitally signed by
Tanisha L. Hithe -S
Hithe -S Date: 2024.05.08
15:28:53 -04'00'
Tanisha Hithe 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
3
Indications for Use
510(k) Number (if known) K233803
Device Name UltraClear Fractional Laser System
Indications for Use (Describe)
The UltraClear Fractional Laser System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytids, furrows, fine lines, textural irregularites, epider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), benign pigmented lesions, and vascular dyschromia.
Fractional Effects:
The UltraClear Fractional Laser System with its accessories when used in intended to produce fractional effects during skin resurfacing
| 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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4
510(k) Summary
UltraClear Fractional Laser System
K233803
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
| Owner/Applicant: | Acclaro Corporation
333 George Washington Highway
Smithfield, RI 02917 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent | Shlomo Assa, President
333 George Washington Highway
Smithfield, RI 02917
619-988-4796
sassa@acclaromd.com |
| Date of Summary: | May 7, 2024 |
| Device Trade Name: | UltraClear Fractional Laser System |
| Common or Usual Name: | 2910 nm laser system |
| Regulation Number: | 21 CFR 878.4810 |
| Device Class: | II |
| Product Code: | GEX |
| Panel: | General and Plastic Surgery |
| Predicate Device: | Joule Profractional System K173285 |
| Reference Device: | UltraClear Fractional Laser System K210847 |
| Device Description: | UltraClear Fractional 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 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. |
5
| Indications for Use: | The UltraClear Fractional Laser System with its accessories is
intended for use in dermatological procedures requiring
coagulation, resurfacing, and ablation of soft tissue. Procedures
include skin resurfacing and treatment of wrinkles, rhytids, furrows,
fine lines, textural irregularities, epidermal nevi, telangiectasia,
spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags,
keratoses, scar revision (including acne scars), benign pigmented
lesions, and vascular dyschromia. |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fractional Effects: | The UltraClear Fractional Laser System with its accessories when
used in Ultra mode is intended to produce fractional effects during
skin resurfacing. |
Technological Comparison to the predicate and reference devices
| Device & Predicate
Device(s): | K233803
(Subject Device) | K173285
(Predicate) | K210847
(Reference) |
|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Light Source | Diode, Er:YAG | Er:YAG | Diode, Er:YAG |
| Wavelength (nm) | 2910 | 2940 | 2910 |
| Modes | CW, pulsed | Pulsed | CW, pulsed |
| Laser power (W) | 10W | 30W | 10W |
| Energy/pulse/µbeam
(mJ/pulse/µbeam) | 0.6-1.5 (Clear
Mode)
1.5-3.0 (Silk
Mode)
3.6-30.0 (Ultra
Mode)
0.6-1.5, 3.6-30.0
(UltraClear-
Mode) | ≤ 70 mJ | 0.6-1.5 (Clear
Mode)
1.5-3.0 (Silk
Mode)
3.6-30.0 (Ultra
Mode)
0.6-1.5, 3.6-30.0
(UltraClear-
Mode) |
| µbeam dia. (µm) | 170 | 450 | 170 |
| Fluence per µ-beam (J/cm²) | 15.9-132.2 | ~3.0 | 15.9-132.2 |
| No. of circles in a spot of
10x10mm | 49-81 rings (clear)
36-64 rings (silk) | - | 49-81 rings (clear)
36-64 rings (silk) |
| Inter µbeam spacing (mm)
(In Ultra mode for subject
device)
Inter ring spacing (mm)
(in clear and ultra mode) | 1.25-0.7 (1.5%-
5%, Ultra)
1.25-1.66 (30-
50%, Clear)
1.43-2.0 (20-40%, Clear) | | 1.25-0.7 (1.5%-
5%, Ultra)
1.25-1.66 (30-
50%, Clear)
1.43-2.0 (20-40%, Clear) |
Confidential
6
| Device & Predicate | K233803 | K173285 | K210847 |
|---|---|---|---|
| Device(s): | (Subject Device) | (Predicate) | (Reference) |
| Silk) | Silk) | ||
| 30-50% (Clear | |||
| mode) | 30-50% (Clear | ||
| mode) | |||
| µbeam density or coverage | |||
| (in a circle or spot) | 20-40% (Silk | ||
| mode) | - | 20-40% (Silk | |
| mode) | |||
| 1.5-5% (Ultra | |||
| mode) | 1.5-5% (Ultra | ||
| mode) | |||
| 30-50% | |||
| (UltraClear mode) | 30-50% | ||
| (UltraClear mode) | |||
| Spot size (mm X mm) | 2X2 – 15X15 | 1.3X1.3 – 20X20 | 2X2 – 15X15 |
| Spot size patterns | Same as above | Same as above | Same as above |
| Repetition Rate (Hz) | 3 | 3 | 3 |
| Pulse duration (ms) | 0.1-3.0 | 0.5-1.5 | 0.1-3.0 |
| Aiming beam | Yes, 650 nm | Yes, red/green | Yes, 650 nm |
| Diode Cooling | Water to air heat | ||
| exchanger | Water to air heat | ||
| exchanger | Water to air heat | ||
| exchanger | |||
| Skin Cooling | No | No | No |
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Technological Characteristics / Substantial Equivalence
The UltraClear Fractional Laser System is substantially equivalent in design, function, operating principles, and intended use to the Joule ProFractional System (K173285) 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, fractional 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
Acclaro Corporation conducted non-clinical performance studies to confirm the overall functional specification testing of the UltraClear Fractional Laser System against its design specifications and intended use.
The following testing was conducted in support substantial equivalence.
Biocompatibility Testing
Testing was conducted in accordance with ISO-10993-1 to demonstrate the patient contacting material of the handpiece is safe for transient use (≤24 hours of contacting).
Electromagnetic Compatibility & Electrical Safety
UltraClear Fractional 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 Ed. 3, 2007-03: 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 Third Edition, 2007-05: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
8
UltraClear Fractional 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 Fractional 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 Fractional Laser System is as safe and effective as its predicate device.