(78 days)
Not Found
No
The summary describes a laser lipolysis system and its components, focusing on the laser technology and its application for fat reduction. There is no mention of AI, ML, image processing, or any data-driven algorithms that would suggest the use of AI/ML.
Yes
The device is intended for non-invasive lipolysis to reduce fat bulges and contour the body, which addresses a health-related condition (excess fat) and provides a therapeutic effect (fat reduction and body contouring).
No
The device is intended for non-invasive lipolysis and body contouring, which are treatment procedures, not diagnostic ones. It does not identify or analyze a condition.
No
The device description explicitly states it consists of a main unit, control unit with dedicated software and user interface, and treatment applicators, indicating it includes hardware components beyond just software.
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 (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Diode Laser Body Sculpture Systems is a device that applies laser energy directly to the body to target and reduce fat cells. This is a physical treatment performed on the patient, not a test performed on a sample from the patient.
- Intended Use: The intended use is for non-invasive lipolysis and affecting the appearance of fat bulges, which is a cosmetic/body contouring procedure, not a diagnostic test.
The device description and intended use clearly indicate it's a therapeutic device used for body contouring, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The Diode Laser Body Sculpture Systems 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. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.
Product codes
PKT
Device Description
The HS-851 Diode Laser Body Sculpture Systems is a 1060nm Diode Hyperthermic Laser Lipolysis system and utilizes the latest technology for non-invasive body contouring. It applies a 1060nm wavelength laser to target the adipose tissue to reduce stubborn fat in areas such as flank, abdomen, back and thighs.
The purpose of the device is to breakdown the fat cells in the target area and in doing so contour the body and reduce the number of fat cells in that area.
The proposed device consists of the main unit, control unit with dedicated software and user interface, and the treatment applicators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen, flanks, back, and thighs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
It is not applicable.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a circular seal with an abstract design. To the right of the seal, the text "FDA U.S. FOOD & DRUG ADMINISTRATION" is displayed in a bold, sans-serif font. The word "FDA" is in a blue square, and the rest of the text is in a smaller font size.
September 10, 2020
Shanghai Apolo Medical Technology Co., Ltd. Mr. Felix Li RA Supervisor Room 301-310, Building 11, No.388, Yindu Road, Xuhui District Shanghai, Shanghai 200231 China
Re: K201731
Trade/Device Name: Diode Laser Body Sculpture System Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: PKT Dated: June 18, 2020 Received: June 24, 2020
Dear Felix Li:
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 medical devices and radiation-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,
Purva Pandya 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) K201731
Device Name Diode Laser Body Sculpture Systems
Indications for Use (Describe)
The Diode Laser Body Sculpture Systems 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. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.
| 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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K201731-510(k) summary
l Submitter
Shanghai Apolo Medical Technology Co., Ltd. Room 301-310, Building 11, No.388, Yindu Road, Xuhui District, 200231, Shanghai China Establishment Registration Number: 3007120647
Contact person: Felix Li Position: Regulatory Affairs Phone: +86-138 4919 0618 Fax: +86-21-34622840 E-mail: liqiang@apolo.com.cn
Date of preparation: Sep 9th, 2020
II Proposed Device
| Trade Name of Device: | Diode Laser Body Sculpture Systems |
|---|---|
| Common name: | Low Level Laser System for Aesthetic Use |
| Regulation Number: | 21 CFR 878.5400 |
| Regulatory Class: | Class II |
| Product code: | PKT |
| Review Panel | General & Plastic Surgery |
III Predicate Devices
| 510(k) Number: | K182741 |
|---|---|
| Trade name: | SculpSure |
| Common name: | Low Level Laser System for Aesthetic Use |
| Classification: | Class II |
| Product Code: | PKT |
| Manufacturer | Cynosure |
| 510(k) Number: | K191068 |
| Trade name: | Powersculp laser lipolysis system |
| Common name: | Low Level Laser System for Aesthetic Use |
| Classification: | Class II |
| Product Code: | PKT |
| Manufacturer | Wuhan Lotuxs Technology Co., Ltd. |
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IV Device description
The HS-851 Diode Laser Body Sculpture Systems is a 1060nm Diode Hyperthermic Laser Lipolysis system and utilizes the latest technology for non-invasive body contouring. It applies a 1060nm wavelength laser to target the adipose tissue to reduce stubborn fat in areas such as flank, abdomen, back and thighs.
The purpose of the device is to breakdown the fat cells in the target area and in doing so contour the body and reduce the number of fat cells in that area.
The proposed device consists of the main unit, control unit with dedicated software and user interface, and the treatment applicators.
V Indication for use
The Diode Laser Body Sculpture Systems 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. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.
| Item | Proposed device | Primary
predicate
device
(K182741) | Secondary
predicate
device
(K191068) | Discussion |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product
Code | PKT | PKT | PKT | Identical |
| Regulation
No. | 21 CFR 878.5400 | 21 CFR 878.5400 | 21 CFR 878.5400 | Identical |
| Class | Class II | Class II | Class II | Identical |
| Indication
for use | This product 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. The | The Cynosure
SculpSure™ is
intended for
non-invasive
lipolysis of the
abdomen,
flanks, back, and
thighs in
individuals with
a Body Mass | The Powersculp
laser lipolysis
system is
intended for
non-invasive
lipolysis of the
flank and
abdomen to
achieve
disruption of | Equivalent |
| | device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs. | Index (BMI) of 30 or less. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a BMI of 49 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area. When using the petite mask for non-invasive lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area. | adipocyte celles intended for non-invasive aesthetic use to achieve a desired aesthetic effect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less. | |
| Laser type | Diode laser | Diode laser | Diode laser | Identical |
| Wavelength | 1060nm±20 nm (infrared) | 1060nm±20 nm (infrared) | 1060nm±20 nm (infrared) | Identical |
| Lipolysis method | Heat-assisted | Heat-assisted | Heat-assisted | Identical |
| Spot size | $4 * 6 cm^2/4 * 8 cm^2$ on each of the Applicator heads (up to four | $4 * 6 cm^2$ on each of the Applicator heads (up to four | $4 * 8 cm^2$ (A single applicator of four applicators) | Equivalent |
| | applicators per
body treatment) | applicators per
body treatment)
14.28 cm² (for
standard
submental
mask)
10.49 cm² (for
petite submental
mask) | | |
| Pulse width | CW | CW | CW | Identical |
| Power
density | 0.8 ~ 1.6W/cm² | Up to 1.4 W/ cm²
(body)
Up to 3.06 W/
cm²
(submental) | Up to 0.7-1.7W/
cm² | Equivalent |
| Attachment
to patient | Belt | Belt | Belt | Identical |
| Voltage | AC110-240V,
50/60Hz, 20-4A | AC200-240V,
50/60Hz, 20A | AC100-240V,
50/60Hz, 15A | Equivalent |
| Peak
power | 35W (per
applicator) for 4 *
6 cm²
50W (per
applicator) for 4 *
8 cm² | 30W (per
applicator) | 50W (per
applicator) | Equivalent |
| Cooling | Contact cooling | Contact cooling | Contact cooling | Identical |
VI Comparison of technological characteristics with the predicate devices
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VII Non-Clinical Testing
A series of tests have been performed to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:
Electrical safety and electromagnetic compatibility
- 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical ● IEC electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment -Part 1-2: General ●
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requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements
- IEC 60601-2-22:2007(third edition)+A1:2012 for use in conjunction with IEC ● 60601-1:2005 (third edition)+A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Biocompatibility Evaluation:
Per FDA's Biocompatibility Guidance issued on June 16, 2016 and with regard to Table A.1 Evaluation Tests for consideration in ISO, "Use of international Standard ISO 10993-1, Biological evaluation of medical - Part 1: Evaluation and testing within a risk management process," the following tests performed on the material which contacts with human for Biocompatibility:
- Cytotoxicity; ●
- Skin irritation; ●
- Skin Sensitization .; ●
VIII Clinical Testing
It is not applicable.
fonclusion substantially equivalent to the predicate device.