(93 days)
Not Found
No
The summary describes a laser system with standard components and control mechanisms (footswitch, LCD touch screen). There is no mention of AI, ML, image processing, or data sets for training or testing, which are typical indicators of AI/ML integration.
Yes
The device is indicated for surgical incision, vaporization, ablation, and coagulation of soft tissue, as well as laser-assisted lipolysis, which are therapeutic procedures.
No
The LipoAI is indicated for surgical procedures (incision, vaporization, ablation, coagulation) and laser-assisted lipolysis, which are therapeutic rather than diagnostic actions. Its description focuses on delivering laser energy for these treatments.
No
The device description clearly outlines multiple hardware components including a laser source, power supply, CPU controller, cooling system, user interface with LCD touch screen, beam delivery system, and footswitch. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical procedures involving the incision, vaporization, ablation, and coagulation of soft tissue, as well as laser-assisted lipolysis. These are all procedures performed on the body, not with samples taken from the body for diagnostic purposes.
- Device Description: The description details a medical laser system that delivers energy through an optical fiber inserted into tissue. This is consistent with a surgical device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly interact with and modify tissue within the body.
N/A
Intended Use / Indications for Use
The LipoAI is indicated for the surgical incision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The LipoAI is further indicated for laser assisted lipolysis.
Product codes
GEX
Device Description
The LipoAl is medical laser equipped with a short pulse 1444 nm Nd:YAG laser source.
The device delivers the laser energy through a 600 um optical fiber. The fiber is protected by a small stainless-steel cannula (max. 1.4mm) and is inserted in the tissue through a small aperture in the skin.
The DEKA LipoAl device consists of:
- An AC/DC power supply unit
- CPU controller
- LASER source
- Cooling system
- User interface with LCD touch screen
- Beam delivery system
Laser activation is controlled by footswitch.
Electrical specifications are:
200-240V ~ single phase, 50/60 Hz, Absorbed electric power 3200 VA (max)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
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)
Electrical safety and EMC testing were conducted on the LipoAl 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, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Additional non-clinical testing conducted
Additional tests were conducted on the LipoAl 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Lutronic AccuSculpt II Laser system (K101573)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 21, 2021
EL.EN Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager VIA Baldanzese 17 Calenzano, Firenze 50041 Italy
Re: K212270
Trade/Device Name: DEKA LipoAI 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 15, 2021 Received: July 20, 2021
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 and Part 809: 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 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.
Purva Pandya 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
510(k) Number (if known) K212270
Device Name DEKA LipoAI
Indications for Use (Describe)
The LipoAI is indicated for the surgical incision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The LipoAI is further indicated for laser assisted lipolysis.
| 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) |
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3
510(k) Summary
DEKA LIPOAI
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:
September 17, 2021
Device Trade Name:
DEKA LIPOAI
Common Name:
Powered Laser Surgical Instrument
Classification Name:
Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology
Product Code:
GEX
Regulatory Class:
Class II
4
Classification Number:
21 CFR 878.4810
Predicate Device:
Lutronic AccuSculpt II Laser system (K101573)
Device Description:
The LipoAl is medical laser equipped with a short pulse 1444 nm Nd:YAG laser source.
The device delivers the laser energy through a 600 um optical fiber. The fiber is protected by a small stainless-steel cannula (max. 1.4mm) and is inserted in the tissue through a small aperture in the skin.
The DEKA LipoAl device consists of:
- An AC/DC power supply unit
- CPU controller
- . LASER source
- Cooling system
- . User interface with LCD touch screen
- . Beam delivery system
Laser activation is controlled by footswitch.
Electrical specifications are:
200-240V ~ single phase, 50/60 Hz, Absorbed electric power 3200 VA (max)
Indications for Use:
The LipoAl is indicated for the surgical incision, excision, vaporization, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The LipoAl is further indicated for laser assisted lipolysis.
5
Comparison with The Predicate Device:
The DEKA LIPOAI is substantially equivalent to the AccuSculpt II Laser system (K101573):
| Device Trade | Proposed Device | Predicate Device | comment |
|---|---|---|---|
| Name | DEKA LipoAI | Lutronic AccuSculpt II | |
| (K101573) | |||
| Indications for | |||
| Use | The LipoAl is indicated for | ||
| the surgical incision, | |||
| excision, vaporization, | |||
| ablation, and coagulation of | |||
| soft tissue. All soft tissue is | |||
| included, such as skin, | |||
| cutaneous tissue, | |||
| subcutaneous tissue, | |||
| striated and smooth tissue, | |||
| muscle, cartilage meniscus, | |||
| mucous membrane, lymph | |||
| vessels and nodes, organs | |||
| and glands. The LipoAl is | |||
| further indicated for laser | |||
| assisted lipolysis. | The AccuSculpt II Laser | ||
| System is indicated for the | |||
| surgical incision, excision, | |||
| vaporization, ablation, and | |||
| coagulation of soft tissue. | |||
| All soft tissue is included, | |||
| such as skin, cutaneous | |||
| tissue, subcutaneous tissue, | |||
| striated and smooth tissue, | |||
| muscle, cartilage meniscus, | |||
| mucous membrane, lymph | |||
| vessels and nodes, organs | |||
| and glands. The AccuSculpt | |||
| II is further indicated for | |||
| laser assisted lipolysis. | Identical | ||
| Regulation | |||
| number | 21 CFR 878.4810 Laser | ||
| surgical instrument for use | |||
| in general and plastic | |||
| surgery and in dermatology | 21 CFR 878.4810 Laser | ||
| surgical instrument for use | |||
| in general and plastic | |||
| surgery and in dermatology | Identical | ||
| Product Code | GEX | GEX | Identical |
| Laser type | • Pulsed Nd:YAG | • Pulsed Nd:YAG | Identical |
| Wavelength | 1444 nm | 1444 nm | Identical |
| Max Pulse Energy | 300 mJ | 300 mJ | Identical |
| Transmission | |||
| system | 600 µm Optical fiber | 600 µm Optical fiber | Identical |
| Pulse width | Up to 100 µs | Up to 100 µs | Identical |
| Device Trade | |||
| Name | Proposed Device | Predicate Device | comment |
| DEKA LipoAI | Lutronic AccuSculpt II | ||
| (K101573) | |||
| Pulse repetition | |||
| rate | 5-40 Hz | 5-40 Hz | Identical |
| Aiming beam | Red and Green visible laser | ||
| diode | Red visible laser diode | Difference does not | |
| affect safety and | |||
| effectiveness of the | |||
| device | |||
| Max Output | |||
| power | 12W | 12 W | Identical |
6
Clinical Performance Data:
None
Non-Clinical Performance Data:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the LipoAl 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, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Additional non-clinical testing conducted
Additional tests were conducted on the LipoAl device, according to the following standards:
7
K212270
. 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 LIPOAI is as safe, as effective, and performs as well as the legally marketed predicate device (K101573).
Additional Information:
None.