810nm Diode Laser System
Device Facts
| Record ID | K183122 |
|---|---|
| Device Name | 810nm Diode Laser System |
| Applicant | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Aug 25, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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.
Device Story
810nm Diode Laser System (Cheveux) provides laser-based dermatological treatments. Device consists of console (power supply, control electronics, user interface) and diode laser handpiece. Operated via footswitch and handswitch in clinical settings. Emits 810nm laser light via diode array; beam delivered through light guide. Used by clinicians for hair removal, permanent hair reduction, and treatment of benign vascular/pigmented lesions, leg veins, and pseudofolliculitis barbae. Benefits include non-invasive management of hair and skin conditions across all Fitzpatrick skin types.
Clinical Evidence
Bench testing only. No clinical data provided. Compliance with electrical safety (IEC 60601-1) and EMC/radiation safety standards (EN 60601-1-2, EN 61000-3-2, EN 61000-3-3) was demonstrated.
Technological Characteristics
Diode laser system; 810nm wavelength; diode array light source; light guide beam delivery. Max energy density 100J/cm²; max pulse width 400ms; spot size 14mm x 10mm. Console-based with footswitch/handswitch activation. Standards: IEC 60601-1, EN 60601-1-2:2015, EN 55011:2009+A1:2010, EN 61000-3-3, EN 61000-3-2.
Indications for Use
Indicated for hair removal, permanent hair reduction, treatment of benign vascular lesions, benign pigmented lesions, leg veins, and pseudofolliculitis barbae in patients of all skin types (Fitzpatrick I-VI), including tanned skin.
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
- 810nm Diode Laser System of Sandstone Medical Technologies, LLC (K100893)
Related Devices
- K100893 — CHEVEUX DIODE LASER SYSTEM · Sandstone Medical Technologies, LLC · Jun 16, 2010
- K113502 — ADVANTAGE LASER SYSTEM · Lutronic Corporation · Apr 5, 2012
- K230580 — Diode Laser System · Smedtrum Medical Technology Co., Ltd. · May 26, 2023
- K141986 — ELUX 810 LASER · Equipmed North America, Inc. · Jan 30, 2015
- K191970 — Diode Laser Hair Removal System · Beijing Sano Laser S&T Development Co.,Ltd · Apr 6, 2020
Submission Summary (Full Text)
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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
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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),<br>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.
