(85 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on laser technology and standard control interfaces.
No
The device is intended for non-invasive lipolysis to affect the appearance of visible fat bulges, not to treat or diagnose a disease or condition. While it has a physical effect on the body (lipolysis), its ultimate goal is cosmetic.
No
This device is intended for non-invasive lipolysis to affect the appearance of visible fat bulges, which is a therapeutic rather than diagnostic function. It is a diode laser device that delivers energy to subcutaneous tissue layers, not one that identifies or diagnoses medical conditions.
No
The device description clearly states it is a "diode laser device" and lists hardware components such as applicators, an LCD control panel, and electrical specifications. This indicates it is a physical medical device, not software-only.
Based on the provided information, the DEKA PHYSIQ 360 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "non-invasive lipolysis of the abdomen, flanks, back, and thighs" and to "affect the appearance of visible fat bulges." This is a therapeutic/aesthetic purpose, not a diagnostic one.
- Device Description: The device is a diode laser that delivers energy to subcutaneous tissue. This is a physical intervention, not a test performed on biological samples outside the body.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The PHYSIQ 360 does not perform any such analysis.
Therefore, the DEKA PHYSIQ 360 is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DEKA PHYSIQ 360 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 PHYSIQ 360 is a diode laser device. The device is provided with:
- Up to 4 applicators that deliver the laser energy to the patient (to subcutaneous tissue layers).
- An LCD control panel with touch-screen technology provides information on the status and settings of the PHYSIQ 360 device to input commands into the system.
- One wavelength, 1060 ±20 nm (infrared)
The PHYSIQ 360 electrical specifications are: 115-230V~ single phase, 50/60Hz, 1200VA (max)
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
Not Found
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)
Clinical Performance Data: None
Non-Clinical Performance Data:
Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the PHYSIQ 360 device, according to the following standards:
- ANSI AAMI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Software Validation and Verification Testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".
Additional tests were conducted on the PHYSIQ 360 device, according to the following standards: - IEC 60601-2-22: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1: Safety of laser products - Part 1: Equipment classification and requirements.
Conclusion: On the basis of the comparison with the predicate device and on the non-clinical performance data, we can conclude that DEKA PHYSIQ 360 is as safe, as effective, and performs as well as the legally marketed predicate device (K171992).
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 26, 2023
El.En. S.p.A Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FI 50141 Italy
Re: K231971
Trade/Device Name: Deka Physiq 360 Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: PKT Dated: June 30, 2023 Received: July 3, 2023
Dear Paolo Peruzzi:
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.
1
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.
Tanisha L. Tanisha L. Hithe -s 2023.09.26 Hithe -S 17:15:35 -04'00'
Tanisha Hithe, MS, MHS 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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
K231971
Device Name
DEKA PHYSIQ 360
Indications for Use (Describe)
The DEKA PHYSIQ 360 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) Summary
DEKA PHYSIQ 360
Submitter:
El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy
Contact:
Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi@elen.it
Date Summary Prepared:
June 30, 2023
Device Trade Name:
DEKA PHYSIQ 360
Common Name:
Laser for aesthetic use
Classification Name:
Laser for disruption of adipocyte cells for aesthetic use
Product Code:
PKT
Regulatory Class:
Class II
4
Classification Number:
21 CFR 878.5400
Predicate Device:
Sculpsure (K171992)
Device Description:
The PHYSIQ 360 is a diode laser device. The device is provided with:
- Up to 4 applicators that deliver the laser energy to the patient (to subcutaneous tissue layers).
- An LCD control panel with touch-screen technology provides information on the status and settings of the PHYSIQ 360 device to input commands into the system.
- One wavelength, 1060 ±20 nm (infrared)
The PHYSIQ 360 electrical specifications are: 115-230V~ single phase, 50/60Hz, 1200VA (max)
Indications for Use:
The PHYSIQ 360 device 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.
5
Comparison with The Predicate Device:
| Device Trade Name | Proposed Device
DEKA PHYSIQ 360 | Predicate Device
Sculpsure (K171992) | Comment |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The DEKA PHYSIQ 360
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. The device is
intended to affect the
appearance of visible fat
bulges in the abdomen,
flanks, back, and thighs. | The Cynosure SculpSure 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. In addition, the
device is intended for non-
invasive lipolysis of the
submental area in
individuals with a BMI of
43 or less. The device is
intended to affect the
appearance of visible fat
bulges in the abdomen,
flanks, back, thighs and
submental area | The proposed
device's indications
for use are a subset
of the predicate's
indications for use.
The proposed and
predicate devices'
key technological
parameters are the
same, and thus the
subset of the
predicate device's
indications for use
are applicable to
the proposed device |
| Regulation number | 21 CFR 878.5400 Laser for
disruption of adipocyte
cells for aesthetic use | 21 CFR 878.5400 Laser for
disruption of adipocyte
cells for aesthetic use | Identical |
| Product Code | PKT | PKT | Identical |
| Device Type | Diode Laser | Diode Laser | Identical |
| Lypolysis Method | Heat-assisted | Heat-assisted | Identical |
| Wavelength | 1060 ±20 nm
(infrared) | 1060 ±20 nm
(infrared) | Identical |
6
| Device Trade Name | Proposed Device | Predicate Device | Comment |
|---|---|---|---|
| DEKA PHYSIQ 360 | Sculpsure (K171992) | ||
| Spot Size | 4 x 6 cm on each of the | ||
| applicator heads | |||
| (up to four applicators per | |||
| body treatment) | 4 x 6 cm on each of the | ||
| applicator heads | |||
| (up to four applicators per | |||
| body treatment) | |||
| 14.28 cm2 (one applicator | |||
| head and frame used for | |||
| Submental treatment) | Identical for the | ||
| proposed | |||
| Indications for Use | |||
| Pulse Width | |||
| (laser ON time) | CW | CW | Identical |
| Power Density | Up to 1.4 W/cm² | ||
| (body) | Up to 1.4 W/cm² | ||
| (body) | |||
| Up to 2.35 W/cm² | |||
| (submental) | Identical for the | ||
| proposed | |||
| Indications for Use | |||
| Attachment to | |||
| patient | Belt (body treatment) | Belt (body treatment) | |
| Headgear and straps | |||
| (submental treatment) | Identical for the | ||
| proposed | |||
| Indications for Use |
Clinical Performance Data:
None
Non-Clinical Performance Data:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the PHYSIQ 360 device, according to the following standards:
. ANSI AAMI ES60601-1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Software Validation and Verification Testing
Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".
7
K231971
Additional non-clinical testing conducted
Additional tests were conducted on the PHYSIQ 360 device, according to the following standards:
- . IEC 60601-2-22: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- . IEC 60825-1: Safety of laser products - Part 1: Equipment classification and requirements.
Conclusion:
On the basis of the comparison with the predicate device and on the non-clinical performance data, we can conclude that DEKA PHYSIQ 360 is as safe, as effective, and performs as well as the legally marketed predicate device (K171992).
Additional Information:
None