Stardust Med
Device Facts
| Record ID | K200736 |
|---|---|
| Device Name | Stardust Med |
| Applicant | I.T.S. Group S.R.L. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Jun 26, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
STARDUST MED is indicated for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical of dermatology and general and plastic surgery. STARDUST MED is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime
Device Story
STARDUST MED is a laser-emitting device for aesthetic and surgical dermatology/plastic surgery. It consists of a main console and an 808 nm diode laser handpiece. Operated by a clinician, the handpiece is applied in contact with the skin and triggered via footswitch or finger switch. A microprocessor-based system controller monitors and directs all system functions and the graphic user interface. The device delivers laser energy to the target area to achieve hair removal and permanent hair reduction. Clinical benefit is realized through long-term, stable reduction in hair count.
Clinical Evidence
Bench testing only. Provided electrical safety and EMC testing per IEC 60601-2-22 and IEC 60601-1-2, and software verification and validation per FDA guidance.
Technological Characteristics
Laser surgical instrument (21 CFR 878.4810). Energy source: 808 nm diode laser. Output: up to 40 J/cm² fluence, 10-300 ms pulse duration, 1-10 Hz repetition rate. Spot size: 1.0x1.0 cm. Operation: CW/pulsed burst. Microprocessor-based system controller with GUI. Power: 110-240 Vac, 50/60Hz. Contact-based handpiece.
Indications for Use
Indicated for hair removal and permanent hair reduction in patients requiring aesthetic, surgical, or cosmetic dermatological and plastic surgery treatments.
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
- MT ONE DIAMOND- M&T SRL (K191942)
Submission Summary (Full Text)
{0}------------------------------------------------
June 26, 2020
Image /page/0/Picture/1 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
I.T.S. Group S.R.L. % Chiara Violini Consultant Endo Engineering SRL Via Del Consorzio, 41 Falconara Marittima, Ancona 60015 Italy
Re: K200736
Trade/Device Name: Stardust Med 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: March 11, 2020 Received: March 23, 2020
Dear Chiara Violini:
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.
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
{1}------------------------------------------------
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 post-marketing safety reporting (21 CFR 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 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 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). 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,
Colin Kejing Chen Acting 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)
K200736
Device Name STARDUST MED
#### Indications for Use (Describe)
STARDUST MED is indicated for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical of dermatology and general and plastic surgery.
STARDUST MED is indicated for hair removal and permanent hair reduction.
Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
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."
EF
{3}------------------------------------------------
Image /page/3/Picture/2 description: The image shows the logo for NTS Group. The logo consists of a blue circle with the letters 'nts' in white, followed by the word 'group' in black. The 'nts' is written in a stylized font, with the 't' and 's' connected.
#### 510(k) Summary ഗ
### Introduction:
This document contains the 510(k) Summary for the STARDUST MED device. The content of this summary is based on the requirements of 21 CFR 807.92(c).
| Applicant/<br>Manufacturer<br>Name and Address: | I.T.S. GROUP s.r.l.<br>Via del Cerchio, 1<br>40012 Calderara di Reno (BO)<br>Italy |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Chiara Violini<br>Consultant<br>Email: c.violini@endoengineering.it<br>Phone: +39-071-9156048<br>Fax: +39-071-0971883 |
| Date Prepared: | 11/03/2020 |
| Device Name: | STARDUST MED |
| Classification: | Class II |
| Classification Name: | Laser surgical instrument for use in general and plastic<br>surgery |
| Regulation number: | 21 CFR 878.4810 |
| Classification product code: | GEX |
| Predicate Device: | MT ONE DIAMOND- M&T SRL - K191942 |
# Description of the device:
STARDUST MED is a laser emitting device that is operated with handpiece in contact with the skin.
STARSDUST MED comprises a main console unit and a handpiece that is triggered by means of footswitch or a finger switch.
A microprocessor based system controller is used to monitor and direct all the system function and the graphic user interface.
The main console can be connected to the following handpiece:
- -808 nm Laser diode.
{4}------------------------------------------------
Image /page/4/Picture/2 description: The image shows the logo for HTS Group. The logo features a blue circle on the left side with the letters 'HTS' in white. To the right of the circle, the word 'group' is written in a thin, black sans-serif font. The logo is simple and modern, with a clean design.
# STARDUST MED
# Intended Use:
STARDUST MED is indicated for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical of dermatology and general and plastic surgery.
STARDUST MED is indicated for hair removal and permanent hair reduction.
Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime
# Comparison of Technological Characteristics:
STARDUST MED utilizes technological characteristics (energy source, control mechanisms) and specifications that are similar to the Predicate Device.
{5}------------------------------------------------
| Image: ITsgroup logo | STARDUST MED | I.T.S. GROUP s.r.l.<br>Via del Cerchio, 1<br>40012 Calderara di Reno<br>(BO) - Italy |
|----------------------|--------------|--------------------------------------------------------------------------------------|
|----------------------|--------------|--------------------------------------------------------------------------------------|
| Specifications | Predicate Device | Device object of 510(k) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name<br>(K number) | MT ONE DIAMOND<br>K191942 | STARDUST MED |
| Submitter | M&T S.r.l. | ITS GROUP S.r.l. |
| Product Code | GEX | GEX |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Regulatory Class | II | II |
| Product Picture | Image: MT ONE DIAMOND | Image: STARDUST MED |
| Mains | 90-110 Vac / 190-230 Vac, 50 Hz/ 60 Hz | 110-240 Vac, 50/60Hz |
| Intended use | MT ONE DIAMOND and its handpiece is indicated<br>for use in aesthetic, surgical and cosmetic<br>applications and in selective treatments required<br>in the medical of dermatology and general and<br>plastic surgery. MT ONE DIAMOND with HR808<br>nm laser handpiece is indicated for hair removal<br>and permanent hair reduction. Permanent hair<br>reduction is defined as the long term, stable<br>reductions in the number of hairs when<br>measured at 6, 9 and 12 months after the<br>completion of a treatment regime | STARDUST MED is indicated for use in aesthetic,<br>surgical and cosmetic applications and in<br>selective treatments required in the medical of<br>dermatology and general and plastic surgery.<br>STARDUST MED is indicated for hair removal and<br>permanent hair reduction. Permanent hair<br>reduction is defined as the long term, stable<br>reductions in the number of hairs when<br>measured at 6, 9 and 12 months after the<br>completion of a treatment regim |
| Wavelength | 808 nm | 808 nm |
| Fluence | Up to 90 J/cm² | Up to 40 J/cm² |
| Pulse duration | 1 to 200 ms | 10 to 300 ms |
| Mode | Cw/pulsed burst | Cw/pulsed burst |
| Repetition rate | Up to 10 Hz | 1 to 10 Hz |
| Spot size | 1.68 cm2 | 1.0x1.0 cm |
{6}------------------------------------------------
Image /page/6/Picture/2 description: The image contains the logo for NTS Group. The logo features a blue circle on the left side with the letters "NTS" in white. To the right of the circle, the word "group" is written in a thin, sans-serif font. The overall design is clean and modern.
# Performance data:
The following performance data are provided in support of the substantial equivalence determination:
# Safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the STARDUST MED device.
The system complies with the IEC 60601-2-22 standards for safety and the IEC 60601-1-2 standard for EMC.
# Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
# Comparison of Intended Use:
STARDUST MED device's Intended Use is the same Intended Use of its predicate device.
# Substantial Equivalence:
The STARDUST MED device has the same intended use, and similar technological characteristics and specifications, compared to the predicate device. Non-clinical testing supports that the device's technological characteristics and performance do not raise new questions regarding the device's safety and efficacy for its intended use. The STARDUST MED device is considered substantially equivalent to the predicate K191942 device..
