(289 days)
Not Found
No
The summary describes a standard diode laser system for hair removal and lesion treatment, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is indicated for the treatment of various medical conditions such as benign vascular lesions, benign pigmented lesions, leg veins, and pseudofolliculitis barbae, which classifies it as a therapeutic device.
No
The device is used for therapeutic purposes like hair removal and treatment of lesions, not for diagnosing conditions.
No
The device description explicitly states it consists of a console, power supply, control electronics, user interface, and a diode laser handpiece, indicating it is a hardware-based system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Cheveux Diode Laser System Function: The Cheveux Diode Laser System is a therapeutic device that uses laser energy to treat conditions on the body (hair removal, vascular lesions, pigmented lesions, etc.). It does not analyze biological specimens.
The description clearly indicates it's a laser system for external treatments, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The Cheveux Diode Laser System is indicated for:
- Hair Removal
- Permanent hair reduction
- Treatment of benign vascular lesions
- . Treatment of benign pigmented lesions
- Treatment of Leg Veins
- . Treatment for pseudofolliculitis barbae
The Cheveux Laser System is intended for use on all skin types (Fitzpatrick Skin types I-VI) including tanned Skin.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The 810nm Diode Laser System consists of a console that houses the power supply, control electronics and user interface and a diode laser handpiece. The device is activated by means of a footswitch and a handswitch.
The Laser System is designed for use in a clinic, which shall be a clean, dry and wellventilated room with a door.
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
The Laser System is designed for use in a clinic
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)
The 810nm Diode Laser System has been conducted related non-clinical tests to identify the substantial equivalence from the preEN 61000-3-2dicate device. The tests include the concerning of electrical safety, EMC and the requirements of radiation safety, test data and report information are included in this submission. IEC 60601-1, EN 60601-1-2 : 2015 (EN 55011: 2009+ A1: 2010), EN 60601-1-2 : 2015, EN 61000-3-3, EN 61000-3-2.
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.
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.
Not Found
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.
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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 acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
Jonathan Hu, Technical Manager Medwheat (Shanghai) Medical Technology Co., Ltd. 2F, Building 9, Lane 561, Nujiang Road (North), Shanghai 200333, China
August 25, 2019
Re: K183122
Trade/Device Name: 810nm Diode 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: July 10, 2019 Received: July 12, 2019
Dear Jonathan Hu:
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 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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Neil R.P. Ogden, MS Assistant Director, THT4A4 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) K183122
Device Name 810nm Diode Laser System
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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Image /page/3/Picture/1 description: The image shows the logo for SWOT. The logo is blue and features the word "SWOT" in a stylized font. There are two lines that intersect the word "SWOT" vertically. The logo also includes the registered trademark symbol.
Date Prepared: Apr 16th, 2018
510(k) Summary
[As required by 21 CFR 807.92]
1. Submitter's Information
| Name of Sponsor: | Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. |
|---|---|
| Address: | 2F, Building 9, Lane 561, Nujiang Road (North), |
| Shanghai 200333, China | |
| Contact Name: | Yvonne Xue |
| Telephone No.: | 0086-021-62642623 |
| Fax No.: | 0086-021-52827988 |
| Email Address: | regulatory@wonderful-sh.com |
2. Correspondent's Information
| Company Name: | Medwheat Shanghai |
|---|---|
| Correspondent Name: | Jonathan Hu |
| Telephone No.: | 0086-021-65181421 |
| Email Address: | Jonathan.hu@medwheat.com |
3. Trade Name, Common Name, Classification
| Trade Name: | 810nm Diode Laser System |
|---|---|
| Common Name: | Medical Laser System |
| Mode Name: | Cheveux |
| Regulation Classification | Instrument, Surgical, Powered, laser |
| Product Code: | GEX |
| Classification Panel: | General and Plastic Surgery |
| Device Class: | II |
4. Identification of Predicate Device(s)
The identified predicates within this submission are as follows: The 810nm Diode Laser System of Sandstone Medical Technologies, LLC has been cleared by FDA through 510(k) No.K100893 (Decision Date—Jun16, 2010).
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510(k) Submission
Image /page/4/Picture/1 description: The image shows the logo for SWOT. The logo is blue and features the word "SWOT" in a stylized font. There are also some abstract shapes and lines in the logo. The logo also has the registered trademark symbol.
5. Description of the Device
The 810nm Diode Laser System consists of a console that houses the power supply, control electronics and user interface and a diode laser handpiece. The device is activated by means of a footswitch and a handswitch.
The Laser System is designed for use in a clinic, which shall be a clean, dry and wellventilated room with a door.
6. Intended Use/Indication for Use
The Cheveux Diode Laser System is indicated for:
- Hair Removal
- Permanent hair reduction
- Treatment of benign vascular lesions
- . Treatment of benign pigmented lesions
- Treatment of Leg Veins
- . Treatment for pseudofolliculitis barbae
The Cheveux Laser System is intended for use on all skin types (Fitzpatrick Skin types I-VI) including tanned Skin.
7. Technological Characteristics
The subject device in this 510(k) uses the same technology that is utilized in the predicate device. A comparison of technological characteristics is provided in the following table:
| Items | 810nm Diode Laser System | Cheveux Diode Laser System in K100893 |
|---|---|---|
| Light Source | Diode Array | Diode Array |
| Wavelength | 810nm | 810nm |
| Energy Density | Up to 100J/cm² | Up to 100J/cm² |
| Spot Size | 14mm x 10mm | 14mm x 10mm |
| Pulse Width | Up to 400ms | Up to 400ms |
| Beam Delivery System | Light Guide | Light Guide |
Diode Laser Handpiece Specification
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Image /page/5/Picture/1 description: The image shows the logo for SWOT. The logo is blue and features the word "SWOT" in a stylized font. There are also some lines and shapes that make up the logo. The logo also has the registered trademark symbol.
8. Discussion of Non-clinical Testing
The 810nm Diode Laser System has been conducted related non-clinical tests to identify the substantial equivalence from the preEN 61000-3-2dicate device. The tests include the concerning of electrical safety, EMC and the requirements of radiation safety, test data and report information are included in this submission. IEC 60601-1, EN 60601-1-2 : 2015 (EN 55011: 2009+ A1: 2010), EN 60601-1-2 : 2015, EN 61000-3-3, EN 61000-3-2.
9. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, it is concluded, basing on performance testing, indication for use, and technology, the subject device is substantially equivalent to the predicate device K100893.