(57 days)
Not Found
No
The summary describes a laser system for lipolysis and focuses on its hardware components, safety features (cooling, temperature control), and compliance with electrical and laser safety standards. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML algorithms.
Yes
The device is intended for non-invasive lipolysis, which is a medical procedure to remove fat, and its use is stated as "Prescriptive Use," indicating a medical application.
No
Explanation: The "Intended Use" section explicitly states that the DioSculpt laser system is intended for "non-invasive lipolysis," which is a treatment or therapeutic procedure, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions.
No
The device description explicitly states it is a "diode laser system" and mentions hardware components like "cooling and electrical systems" and "applicators," indicating it is a hardware-based medical device, not software-only.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- DioSculpt's Function: The DioSculpt laser system is a device that applies laser energy directly to the body (specifically, the abdomen, flanks, back, and thighs) for non-invasive lipolysis (fat reduction). It does not analyze samples taken from the body.
The information provided clearly describes a therapeutic device used for a cosmetic/aesthetic procedure, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The DioSculpt laser system is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less.
Product codes
PKT
Device Description
The DioSculpt laser lipolysis system is a diode laser system, Electrically efficient semiconductor generate optical radiation (1060nm) which is used to deliver laser energy to subcutaneous tissue layers. DioSculpt's cooling and electical systems assist in maintaining safe and comfortable skin surface temperatures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
abdomen, flanks, back, and thighs
Indicated Patient Age Range
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Intended User / Care Setting
Prescriptive Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing
The performance testing were conducted on DioSculpt. The system complied with IEC60601-2-22:2019 and IEC 60825-1:2014.
To guarantee the safety, two temperature testing were conducted to measure the four applicators temperature in worst-case scenario and real operation scenario. All testing results do not exceed maximum allowable temperature of 41℃.
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." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury, either to patient or to a user of device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
September 23, 2022
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. Lily Zhou Management Representative 2F, Building 11, Lane 1175, Tongpu Rd. Shanghai, Shanghai 200333 China
Re: K222265
Trade/Device Name: Diosculpt Regulation Number: 21 CFR 878.5400 Regulation Name: Low level laser system for aesthetic use Regulatory Class: Class II Product Code: PKT Dated: November 14, 2021 Received: July 28, 2022
Dear Lily Zhou:
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
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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 (OS) 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,
Jianting Wang 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
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Indications for Use
510(k) Number (if known) K22265
Device Name DioSculpt
Indications for Use (Describe)
The DioSculpt laser system is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less.
Type of Use (Select one or both, as applicable)
| ☑ Prescriptive Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| ------------------------------------------------ | ----------------------------------------------- |
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 going through the letters "S" and "W". There is a registered trademark symbol in the upper right corner of the logo.
Date Prepared: Sep. 6th, 2022
510(k) Summary
(As required by 21 CFR 807.92)
l. SUBMITTER
| Name of Sponsor: | Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. |
|---|---|
| Address: | 2F, Building 11, Lane 1175, TongPu Rd., |
| Shanghai 200333, China | |
| Contact Name: | Lily Zhou |
| Telephone No.: | 0086-021-62642623 |
| Fax No.: | 0086-021-52827988 |
| Email Address: | laser@wonderful-sh.com |
II. DEVICE
| Trade Name: | Diosculpt |
|---|---|
| Common Name: | Low Level Laser for Lipolysis |
| Model Name: | Diosculpt |
| Regulation Classification | Low Level Laser System for Aesthetic Use |
| Product Code: | PKT |
| Classification Name: | Laser for disruption of adipocyte cells for aesthetic use |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | II |
| Regulation Number: | 21 CFR 878.5400 |
III. PREDICATE DEVICE
The identified predicates within this submission are as follows:
Primary Predicate Device: The Cynosure Sculpsure Low Level Laser System for Aesthetic Use has been cleared by FDA through 510(k) No.K171992 (Decision Date-September 26, 2017).
Secondary Predicate Device: K191068, Powersculp laser lipolysis system, Wuhan Lotuxs Technology Co.,Ltd.(Decision Date-July 17, 2019)
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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 two horizontal lines that run through the word "SWOT", and there is a circle with an R in it in the upper right corner of the logo. The logo is simple and modern, and it is likely used to represent a company or organization.
DEVICE DESCRIPTION IV.
The DioSculpt laser lipolysis system is a diode laser system, Electrically efficient semiconductor generate optical radiation (1060nm) which is used to deliver laser energy to subcutaneous tissue layers. DioSculpt's cooling and electical systems assist in maintaining safe and comfortable skin surface temperatures.
V. INDICATIONS FOR USE
The DioSculpt laser system is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less.
VI. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
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:
| 510(k) Number | K 222265 | K171992 | K191068 |
|---|---|---|---|
| Lipolysis Method | Heat-assisted | Heat-assisted | Heat-assisted |
| Device Type | Diode Laser | Diode Laser | Diode Laser |
| Wavelength | 1060±20nm | ||
| (infrared) | 1060±20nm | ||
| (infrared) | 1060±20nm | ||
| (infrared) | |||
| Pulse Width | CW | CW | CW |
| Energy Density | Up to 1.8W/cm² | Up to 1.4W/cm² | Up to 1.7W/cm² |
| Spot Size | 4*8 cm² on each | ||
| of Applicators | 4*6 cm² on each | ||
| of Applicators | 4*8 cm² on each | ||
| of Applicators | |||
| Peak power per | |||
| applicator | 57.6W | 33.6W | 50W |
| Cooling | Self-contained | ||
| closed loop | Self-contained | ||
| closed loop | Self-contained | ||
| closed loop | |||
| Attachment to | |||
| patient | Belt | Belt | Belt |
Discussion
The energy density of DioSculpt is 0.1W/cm² higher than the predicate device K191068, and the peak power energy is accordingly slightly higher. The higher energy may generate higher temperature to skin. To quarantee the safety, two temperature testing were conducted to measure the four applicators temperature in worst-case scenario and real operation
scenario. All testing results do not exceed maximum allowable temperature of 41°C .
The temperature testing result demonstrates the minor difference in energy and peak power per applicator does not raise safety concerns.
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VII. NON-CLINICAL TESTING
Biocompatibility testing
The biocompatibility evaluation for DioSculpt was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
The applicators are considered tissue contacting, which is categorized as "Surface device", " Intact skin contact", and "with a limited contact duration of less than 24 hours", the following tests were evaluated:
- O Skin Sensitization
- O In Vitro Cytotoxicity
- O Intracutaneous Reactivity
Electrical Safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on DioSculpt. The system complies with the AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012 standards for safety and IEC 60601-1-2:2014 standard for EMC.
Performance Testing
The performance testing were conducted on DioSculpt. The system complied with IEC60601-2-22:2019 and IEC 60825-1:2014.
To guarantee the safety, two temperature testing were conducted to measure the four applicators temperature in worst-case scenario and real operation scenario. All testing results do not exceed maximum allowable temperature of 41℃ .
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." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury, either to patient or to a user of device.
VIII. 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 the same or similar to the predicate device K171992 and K191068.