TitanPico Laser Workstation (PICO-450)
Device Facts
| Record ID | K233757 |
|---|---|
| Device Name | TitanPico Laser Workstation (PICO-450) |
| Applicant | Rhein Laser Technologies Co., Ltd. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Apr 11, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The TitanPico Laser Workstation is indicated for the following at the specified wavelength: 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. The TitanPico Laser Workstation is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
Device Story
TitanPico Laser Workstation is a laser system delivering 532nm and 1064nm wavelengths; utilizes Nd:YAG laser technology to deliver energy pulses; disrupts tattoo dye or pigment particles under skin without harming surrounding tissue; fragmented particles surface and fade as epidermal layer renews. Operated by clinicians in clinical settings; controlled via touchscreen GUI and foot-switch. System includes articulated arm with wavelength zoom handpiece; water-cooled. Output is laser energy; healthcare providers use device to treat tattoos and pigmented lesions; benefits patients through removal of unwanted pigment/tattoos.
Clinical Evidence
Bench testing only. No clinical data provided. Device relies on substantial equivalence to legally marketed predicates. Non-clinical testing included software verification/validation, power output verification, electromagnetic compatibility (IEC 60601-1-2), electrical safety (IEC 60601-1, IEC 60601-2-22), laser safety (IEC 60825-1), and biocompatibility (ISO 10993-1, -5, -10, -23).
Technological Characteristics
Nd:YAG laser system; 532nm/1064nm wavelengths; 375-450ps pulse duration; 1-10Hz repetition rate; 2-10mm spot size; 6.25 J/cm² max average fluence. Water-cooled; articulated arm delivery; touchscreen GUI. Electrical: ~110V, 60Hz. Biocompatible patient-contacting materials per ISO 10993. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1.
Indications for Use
Indicated for tattoo removal (532nm: Fitzpatrick I-III, red/yellow/orange; 1064nm: Fitzpatrick I-VI, black/brown/green/blue/purple) and benign pigmented lesion removal (Fitzpatrick I-IV).
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
{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.
April 11, 2024
Rhein Laser Technologies Co., Ltd. Na Wu Quality Manager 801,8F, E2Building, Future City, No.999 High-Tech Avenue East Lake High-Tech Development Zone Wuhan, 430206 China
Re: K233757
Trade/Device Name: TitanPico Laser Workstation (PICO-450) 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 24, 2023 Received: November 24, 2023
Dear Na Wu:
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 (the 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.
{1}------------------------------------------------
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).
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 QS 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 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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.04.11
14:40:00 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical
{2}------------------------------------------------
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) K233757
Device Name TitanPico Laser Workstation (PICO-450)
Indications for Use (Describe)
The TitanPico Laser Workstation is indicated for the following at the specified wavelength:
532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors:
black, brown, green, blue and purple.
The TitanPico Laser Workstation is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
Type of Use (Select one or both, as applicable)
| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
# Section 5 - 510(k) Summary
# K233757 Date of Modification: April 10, 2024
## 1. Submitter's Identifications
Submitter's Name: Rhein Laser Technologies Co., Ltd. Address: 801,8F, E2 Building, Future City, No.999 High-Tech Avenue, East Lake High-Tech Development Zone, Wuhan 430206, China( Free Trade Zone Wuhan Area) Contact Person: Na Wu Contact Title: Quality Manager Contact Email Address: na.wu@lotuxs.com Telephone: +86-027-65279157
## 2. Correspondent's Identifications
Correspondent's Name: Rhein Laser Technologies Co., Ltd. Address: 801,8F, E2 Building, Future City, No.999 High-Tech Avenue, East Lake High-Tech Development Zone, Wuhan 430206, China ( Free Trade Zone Wuhan Area) ZIP Code: 430206 Contact Person: Na Wu Contact Title: Quality Manager Contact E-mail Address: na.wu@lotuxs.com Telephone: +86-027-65279157
#### 3. Name of the Device
Device Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Product Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Trade Name: TitanPico Laser Workstation Model: PICO-450 Classification Panel: General & Plastic Surgery Product Code: GEX Regulation Number: 21 CFR 878.4810 Device Classification: Class II
# 4. The Predicate Devices
Primary Predicate device: K153527 PicoWay Laser System; K220853 PicoWay Laser System
{5}------------------------------------------------
## 5. Device Description
TitanPico Laser Workstation is a laser system that delivers energy in the 532nm and 1064nm wavelength. The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed.
## 6. Intended Use of Device
The TitanPico Laser Workstation is indicated for the following at the specified wavelength:
532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
The TitanPico Laser Workstation is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
{6}------------------------------------------------
# 7. Summary of Substantial Equivalence
| 'able<br>1 | T | | | 1 |
|------------|---|--|--|---|
|------------|---|--|--|---|
| | Proposed device | Primary Predicate | Secondary Predicate | Comparison |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510k Number | K233757 | K153527 | K220853 | ------- |
| Product Code | GEX | GEX | GEX | Same |
| Proprietary Name | TitanPico Laser Workstation | PicoWay Laser System | PicoWay Laser System | ------- |
| Model | PICO-450 | / | / | ------- |
| Manufacturer | Rhein Laser Technologies Co.,<br>Ltd. | SYNERON<br>CORPORATION | Danielle Gibboney | ------- |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Class | Class II | Class II | Class II | Same |
| Indications for use | The TitanPico Laser Workstation<br>is indicated for the following at<br>the specified wavelength:<br>532nm: Removal of tattoos for<br>Fitzpatrick skin types I-III to treat<br>the following tattoo colors: red,<br>yellow and orange.<br>1064nm: Removal of tattoos for<br>all skin types (Fitzpatrick I-VI) to<br>treat the following tattoo colors:<br>black, brown, green, blue and | The PicoWay Laser System is<br>indicated for the following at the<br>specified wavelength:<br>532nm: Removal of tattoos for<br>Fitzpatrick skin types I-III to treat<br>the following tattoo colors: red,<br>yellow and orange.<br>1064nm: Removal of tattoos for<br>all skin types (Fitzpatrick I-VI) to<br>treat the following tattoo colors:<br>black, brown, green, blue and | The PicoWay laser system is<br>indicated for the following at the<br>specified wavelength:<br>532 nm: Removal of tattoos for<br>Fitzpatrick Skin Types I-III to<br>treat the following tattoo colors:<br>red, yellow and orange.<br>730 nm: Removal of tattoos for<br>Fitzpatrick Skin Types I-IV to<br>treat the following tattoo colors:<br>green and blue. | Same |
{7}------------------------------------------------
| purple.<br>The TitanPico Laser Workstation<br>is also indicated for benign<br>pigmented lesions removal for<br>Fitzpatrick Skin Types I-IV. | purple.<br>The PicoWay Laser System is<br>also indicated for benign<br>pigmented lesions removal for<br>Fitzpatrick Skin Types I-IV. | 785 nm: Removal of tattoos for<br>Fitzpatrick Skin Types II-IV to<br>treat the following tattoo colors:<br>green and blue.<br>1064 nm: Removal of tattoos for<br>all Fitzpatrick Skin Types to<br>treat the following tattoo colors:<br>black, brown, green, blue<br>and purple.<br>The PicoWay laser system is<br>also indicated for benign<br>pigmented lesions removal for<br>Fitzpatrick Skin Types I-IV.<br>The Resolve handpiece (1064<br>nm) is also indicated for the<br>treatment of acne scars in<br>Fitzpatrick Skin Types II-V and<br>for<br>treatment of Melasma for<br>Fitzpatrick Skin Types I-IV.<br>The Resolve handpieces (532<br>nm HE, 532 nm, and 1064 nm)<br>are also indicated for the<br>treatment of wrinkles in<br>Fitzpatrick Skin Types I-IV.<br>The Resolve Fusion handpiece |
|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
{8}------------------------------------------------
| | | | (532 nm) is indicated for benign pigmented lesions removal for Fitzpatrick Skin Types IIV.<br>The PicoWay laser system is indicated for the following at the specified wavelengths:<br><br><b>532 nm:</b><br>Treatment of Melasma for Fitzpatrick Skin Types I-IV.<br>Treatment of caf6 au lait macules (CALMs) for Fitzpatrick Skin Types I-IV.<br>Treatment of Lentigines for Fitzpatrick Skin Types I-IV.<br><br><b>730 nm:</b><br>Treatment of Lentigines for Fitzpatrick Skin Types I-IV.<br><br><b>1064 nm:</b><br>Treatment of Melasma for Fitzpatrick Skin Types I-IV.<br>Treatment of Nevus of Ota for Fitzpatrick Skin Types III-IV. | |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of Use | Prescription Use | Prescription Use | Prescription Use | Same |
| Wavelength | 1064/532 nm | 1064/532 nm | 1064/785/730/532 nm | Same |
| Maximum Energy | 400mJ(1064nm) | 450mJ(1064nm) | Unknown | Similar |
| | 200mJ (532nm) | 220mJ (532nm) | | The maximum<br>energy of the<br>proposed device<br>is similar to the<br>predicate<br>device, so this<br>definition does<br>not affect the<br>safety and<br>effectiveness. |
| Aiming Beam | 635nm | 635nm | 635nm | Same |
| Repetition Rate | 1-10Hz | 1~10Hz | 1~10Hz | Same |
| Spot size | Φ2-10mm | Φ 2mm-10mm | Φ 2mm-10mm | Same |
| Maximum Average<br>Fluence ( J/cm²) | 6.25 J/cm² | 5.7 J/cm²(1064nm)<br>3.2 J/cm²(532nm) | 6.25 J/cm² | Same<br>The maximum<br>average<br>fluence of the<br>submitted<br>device is the<br>same as the<br>predicate device<br>K220853. |
| Pulse Duration | 375-450ps | 240-750ps | 240-500 ps | Same |
| Laser Type | Nd: YAG | Nd: YAG | Nd: YAG | Same |
| Activation | Foot-switch | Foot-switch | Foot-switch | Same |
| User Interface | Touchscreen with GUI | Touchscreen with GUI | Touchscreen with GUI | Same |
| Warm Up Time | 2 minutes | 2 minutes | 2 minutes | Same |
| Cooling method | Water cooling | Water cooling | Water cooling | Same |
| Electrical<br>Power | ~110V , 60Hz | 100 - 240 VAC, 50/60 Hz, | 200-240 VAC, 50/60 HZ, 4600 VA single | Different<br>The electrical power of the proposed device is different from the subject predicate K153527. The proposed device has passed safety testing. This difference will not improve the safety and effectiveness of the proposed device. |
| Delivery System | Articulated arm with wavelength Zoom handpiece | Articulated arm with 2 wavelength Zoom handpiece | Articulated arm with 4 wavelength Zoom handpiece | Same |
| System dimension | 1035mm×805mm×380mm | 42" H x 18" W x 27" D / 107 cm H x 46 cm W x 69 cm D | | Different<br>The system dimension of the |
| | | | | proposed device is |
| | | | | different from the |
| | | | | subject predicate<br>K153527. The |
| | | | Unknown | proposed device<br>has passed safety<br>testing. This<br>difference will not<br>improve the safety<br>and effectiveness<br>of the proposed<br>device. |
| Software | Yes | Yes | Yes | Same |
| Delivery Devices (How<br>supplied) | Non -Sterile. reusable. cleanable | Non -Sterile. reusable. cleanable | Non -Sterile. reusable. cleanable | Same |
| Electromagnetic<br>compatibility and<br>electrical safety<br>compliance | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60825-1<br>IEC 60601-2-22 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60825-1<br>IEC 60601-2-22 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60825-1<br>IEC 60601-2-22 | Same |
| Discussion for<br>Substantially<br>Equivalent (SE) | The proposed device TitanPico Laser Workstation products has the same purpose as the predicate device: product code,<br>Regulation No., Class , Controls, indications for use, Type of Use, wavelength, Maximum Energy, Aiming Beam , Repetition<br>Rate, Spot size, Maximum Average Fluence, Laser Type, Activation, User Interface, Warm Up Time, Cooling method,<br>Delivery System, Software, delivery devices and Electromagnetic compatibility and electrical safety compliance.<br>The difference only exists in such contents: Electrical Power and System dimension. These items can be controlled within the<br>scope of application. These small differences between the proposed devices and predicate devices do not cause new safety<br>and effectiveness problems. According to the non clinical test results, the proposed device is as safe, effective and has good | | | |
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
| performance as the predicate device. |
|--------------------------------------------------------------------------------------------------------------------|
| So the proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. |
{13}------------------------------------------------
#### 8. Non-Clinical Tests Submitted:
Software verification and validation was performed, and it was demonstrated that the software performs as intended according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Testing confirmed that the power output meets specification. Electromagnetic compatibility and electrical safety testing was performed per standards IEC 60601-1 Edition 3.2 (Medical electrical equipment - Part 1: General requirements for basic 2020-08 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 disturbances - Requirements and tests) , IEC 60601-2-22 Edition 3.1 2012-10 (Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical cosmetic therapeutic and diagnostic laser equipment) and IEC 60825-1:2014 (Third Edition)Safety of laser products - Part 1: Equipment classification and requirements [Including: Technical Corrigendum 1 (2008) Interpretation Sheet 1 (2007) Interpretation Sheet 2 (2007)]. Results confirmed the device meets the standards. All patient contacting materials were assessed as per ISO10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, ISO10993-10 Fourth edition 2021-11: Biological evaluation of medical devices - Part 10: Tests for skin sensitization, ISO10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation, ISO10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and found to be biocompatible.
#### 9. Clinical Tests Submitted:
Summary of Substantial Equivalence" submitted of the proposed device, the proposed device series products is Substantially Equivalent (SE) to the predicate device, includes: Product code, Regulation No., Class , Controls, indications for use, Type of Use, wavelength, Maximum Energy, Aiming Beam , Repetition Rate, Spot size, Maximum Average Fluence , Laser Type, Activation, User Interface, Warm Up Time, Cooling method, Delivery System, Software, delivery devices and Electromagnetic compatibility and electrical safefy compliance. the non-clinical tests complied with the requirements of relevant recognized standards, and passed the bench tests (such as performance tests, storage condition tests), so Rhein belives that the proposed device TitanPico Laser Workstation products does not need to carry out clinical tests, and the clinical study data that have been the legally marketed device can be used for reference.
#### 10. Conclusions drawn from clinical and non-clinical tests submitted:
Rhein believes that TitanPico Laser Workstation products is substantially equivalent to its predicate devices with same indications for use, similar technological characteristics. The non-clinical data for TitanPico Laser Workstation products supports the safety of the device and the biocompatibility, hardware and software
{14}------------------------------------------------
verification and validation demonstrate that the TitanPico Laser Workstation products should perform as intended in the specified use conditions.
--- End of this section ---
