(105 days)
Not Found
No
The description focuses on the physical mechanism of the laser (picosecond pulses, wavelengths) and its effect on pigments, with no mention of AI or ML for image analysis, treatment planning, or any other function.
Yes
The device is used for surgical and aesthetic applications, specifically for the removal of tattoos and benign pigmented lesions, which involves altering body structure and function for therapeutic purposes.
No
The device is a Picosecond Nd: YAG Laser System intended for surgical and aesthetic applications, specifically for tattoo removal and treatment of benign pigmented lesions. It uses laser energy to break down pigments, which is a therapeutic function, not diagnostic.
No
The device description clearly describes a physical laser system with specific wavelengths, pulse widths, and energy outputs, indicating it is a hardware device. The performance studies also focus on engineering testing of laser energy output and electrical safety, further confirming it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The description clearly states that this device is a laser system used for surgical and aesthetic applications, specifically for removing tattoos and benign pigmented lesions. It works by applying laser energy directly to the body to break down pigments.
- Lack of Sample Analysis: There is no mention of the device analyzing any samples taken from the body. Its function is entirely based on interacting with the tissue in vivo.
The device is a therapeutic and aesthetic medical device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Picosecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery: such as tattoos removal and benign pigmented lesions.
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, blue, green and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Picosecond Nd: YAG Laser Systems, pulse width:
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
April 30, 2024
Smedtrum Medical Technology Co., Ltd. Crimson Wu Senior Regulatory Engineer 1F., No. 8, Ln. 97, Wugong Rd., New Taipei City, Xinzhuang Dist. 248016 Taiwan
Re: K240118
Trade/Device Name: Picosecond Nd:YAG 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: March 29, 2024 Received: March 29, 2024
Dear Crimson 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 (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/cdrb/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).
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 b Tanisha Hithe -S 11:46:33 -04'00
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & 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) K240118
Device Name
Picosecond Nd:YAG Laser System
Indications for Use (Describe)
The Picosecond Nd: Y AG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery: such as tattoos removal and benign pigmented lesions.
1064nm wavelength:
-
Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, blue, green and purple.
-
Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
-
Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
-
Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
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
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Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016 , Taiwan TEL:+886 (02) 2298 9578 FAX:+886 (02) 2298 9426
K240118, 510(k) Summary Picosecond Nd: YAG Laser System
SUBMITTER I.
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., Xinzhuang Dist., New Taipei City 248016, Taiwan (R.O.C.) Contact Person
Crimson Wu Position: Senior Regulatory Engineer Tel: +886-2-2298-9578, Ext. 301 Fax: +886-2-2298-9426 E-mail: crimsonwu@smedtrum.com Date of preparation: Jan 16th, 2024
II. DEVICE
| Trade Name: | Picosecond Nd:YAG Laser System |
|---|---|
| Common or Usual Name: | Surgical Laser Device |
| Product code: | GEX |
| Regulation Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology |
21 C.F.R. § 878.4810, Device Class II
PREDICATE DEVICE III.
| Manufacturer | Shanghai Apolo Medical Technology Co., Ltd. |
|---|---|
| Trade Name: | PicoSecond Nd: YAG Laser System |
| Common or Usual Name: | Surgical Laser Device |
| Regulation Name: | Laser Surgical Instrument For Use In General And |
| Plastic Surgery And In Dermatology | |
| 21 C.F.R. § 878.4810, Device Class II | |
| Premarket Notification: | K200116 May 28th, 2020 |
IV. DEVICE DESCRIPTION
Picosecond Nd: YAG Laser Systems, pulse width: