Rosso

K211228 · Quanta System Spa · GEX · Feb 2, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K211228
• Device Name: Rosso
• Applicant: Quanta System Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 2, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

694 nm nanosecond (QS mode) Indicated for: Tattoo removal: Suggested for blue, sky blue, black, green and violet ink; Pigmented lesion removal (benign): - Cafe au lait spot - Ephalides, solar lentigo lentigines - Becker Nevus - Ota and Ito Nevus - Nevus spilus - Mongolian spot. 694 nm picosecond (PS mode) Indicated for treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III.

Device Story

Rosso is a laser surgical instrument for dermatology. It emits 694 nm laser energy in both nanosecond (QS) and picosecond (PS) modes. Device is used by physicians in clinical settings for tattoo removal and treatment of benign pigmented lesions. Laser energy targets specific ink colors or pigmented skin lesions. Clinical benefit includes removal of tattoos and benign pigmented lesions. Operation is performed by trained medical professionals.

Technological Characteristics

Laser surgical instrument; 694 nm wavelength; operates in nanosecond (QS) and picosecond (PS) modes; Class II device (21 CFR 878.4810).

Indications for Use

Indicated for tattoo removal (blue, sky blue, black, green, violet ink) and benign pigmented lesion removal (cafe au lait, ephalides, solar lentigo, Becker Nevus, Ota/Ito Nevus, nevus spilus, Mongolian spot) using 694 nm nanosecond mode. Indicated for benign pigmented lesion treatment in Fitzpatrick skin types I-III using 694 nm picosecond mode.

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.

Submission Summary (Full Text)

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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.

February 2, 2022

Quanta System SpA Dario Bandiera Regulatory Affairs Manager Via Acquedotto 109 Samarate, 21017 Varese Italy

Re: K211228

Trade/Device Name: Rosso 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: February 10, 2021 Received: April 23, 2021

Dear Dario Bandiera:

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-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 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 ([e-mail]) or phone [phone] 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) K211228

Device Name Rosso

| Indications for Use ( <i>Describe</i> ) | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------|
| 694 nm nanosecond (QS mode) | |
| Indicated for: | Tattoo removal: Suggested for blue, sky blue, black, green and violet ink; |
| | Pigmented lesion removal (benign): |
| | - Cafe au lait spot |
| | - Ephalides, solar lentigo lentigines |
| | - Becker Nevus |
| | - Ota and Ito Nevus |
| | - Nevus spilus |
| | - Mongolian spot. |
| 694 nm picosecond (PS mode) | |
| | Indicated for treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III. |

| Type of Use ( <i>Select one or both, as applicable</i> ) | | | |
|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| | <table border="0"><tr><td><span style="font-size: 20px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</td><td><span style="font-size: 20px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <span style="font-size: 20px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="font-size: 20px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | |

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