(26 days)
No
The summary describes a pulsed light and RF device for dermatological procedures. There is no mention of AI, ML, image processing, or any data-driven algorithms for diagnosis, treatment planning, or image analysis. The modifications described are hardware-based (filter replacement).
Yes
The device is indicated for photocoagulation of dermatological benign vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions, and noninvasive treatment of mild to moderate facial wrinkles and rhytides, all of which are medical treatments for conditions.
No
The device is indicated for treatment of various dermatological conditions, not for diagnosing them.
No
The device description explicitly details hardware components including pulsed light handpieces, an RF handpiece, a main unit, a flexible cable, a Xenon flashlamp, and electrodes. It also mentions modifications to a filter within a handpiece. This is clearly a hardware-based medical device with potential software control, but not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The DEKA LOTUS device uses pulsed light and radiofrequency energy applied directly to the patient's skin for therapeutic purposes (photocoagulation, photothermolysis, treatment of lesions and wrinkles). It does not analyze samples taken from the body.
- Intended Use: The intended uses described are all related to treating dermatological conditions and wrinkles by applying energy to the skin.
Therefore, the DEKA LOTUS is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
• The DEKA LOTUS 570mm pulsed light handpiece is indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
· The DEKA LOTUS 500G pulsed light handpiece is intended for treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
· The DEKA LOTUS RF handpiece is indicated for use in dermatologic and general surgical procedures for the noninvasive treatment of mild to moderate facial wrinkles and rhytides.
Product codes (comma separated list FDA assigned to the subject device)
ONF, GEI
Device Description
The DEKA LOTUS is a device provided with two pulsed light handpieces and a RF handpiece.
The two pulsed light handpieces have a built-in cooled waveguide which differ in emission spectrum, connected to the main unit through a flexible multifunctional cable.
The handpiece uses a linear Xenon flashlamp, emitting a broad spectrum of electromagnetic radiation (light) when energized.
The RF handpiece produces a particular electric current at 1MHz that induces a molecular oscillation on the cells, raising their temperature locally. The RF current flows through the special electrodes, forming a homogeneous heat area.
The modifications to the device respect to DEKA LOTUS (K233473) consist of replacement of the filter of 590nm Intensed Pulsed Light Handpiece with a 570nm filter. The intended use of modified device, as described in the labelling, has changed as a result of the modifications. Labelling itself has been updated accordingly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
None.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 26, 2025
El.En. S.p.A. Peruzzi Paolo Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FI 50041 Italv
Re: K250281
Trade/Device Name: Deka Lotus 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: ONF, GEI Dated: January 31, 2025 Received: January 31, 2025
Dear Peruzzi Paolo:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE -C Date: 2025.02.26
15:39:22 -05'00'
Tanisha Hithe 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
3
Indications for Use
510(k) Number (if known) K250281
Device Name DEKA LOTUS
Indications for Use (Describe)
• The DEKA LOTUS 570mm pulsed light handpiece is indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
· The DEKA LOTUS 500G pulsed light handpiece is intended for treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
· The DEKA LOTUS RF handpiece is indicated for use in dermatologic and general surgical procedures for the noninvasive treatment of mild to moderate facial wrinkles and rhytides.
| 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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510(k) Summary #K250281
DEKA LOTUS – Special 510(k)
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:
January 30, 2025
Device Trade Name:
DEKA LOTUS
Common Name:
Medical Intense Pulsed Light and RF system.
Regulation Name:
Powered light-based non-laser surgical instrument with thermal effect, Electrosurgical cutting and coagulation device and accessories.
Product Code:
ONF, GEI
Regulatory Class:
Class II
Regulation Number:
21 CFR 878.4810 21 CFR. 878.4400
Predicate Devices:
Quanta Chrome (K202503) DEKA LOTUS (K233473)
Device Description:
5
The DEKA LOTUS is a device provided with two pulsed light handpieces and a RF handpiece.
The two pulsed light handpieces have a built-in cooled waveguide which differ in emission spectrum, connected to the main unit through a flexible multifunctional cable.
The handpiece uses a linear Xenon flashlamp, emitting a broad spectrum of electromagnetic radiation (light) when energized.
The RF handpiece produces a particular electric current at 1MHz that induces a molecular oscillation on the cells, raising their temperature locally. The RF current flows through the special electrodes, forming a homogeneous heat area.
The modifications to the device respect to DEKA LOTUS (K233473) consist of replacement of the filter of 590nm Intensed Pulsed Light Handpiece with a 570nm filter. The intended use of modified device, as described in the labelling, has changed as a result of the modifications. Labelling itself has been updated accordingly.
Indications for Use:
The DEKA LOTUS 570 nm Pulsed Light handpiece Indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
The DEKA LOTUS 500G Pulsed Light handpiece is intended for treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of benign vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
The DEKA LOTUS RF handpiece is intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
Comparison with The Predicate Device:
The DEKA LOTUS is substantially equivalent to Quanta Chrome (K202503), DEKA LOTUS (K233473):
| Device Trade
Name | Proposed 510(k) Device | Reference Device
K202503
QUANTA Chrome
IPL 570-1200 nm | Comments |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Indications for
Use | DEKA LOTUS
Indicated for photocoagulation
of dermatological benign
vascular lesion (i.e. face
telangiectasia),
photothermolysis of blood
vessels (treatment of facial and
leg veins), and treatment of
benign pigmented lesions. | Indicated for photocoagulation of
dermatological benign vascular
lesion (i.e. face telangiectasia),
photothermolysis of blood vessels
(treatment of facial and leg
veins), and treatment of benign
pigmented lesions. | Identical |
570nm Pulsed light handpiece
6
| Device Trade
Name | Proposed 510(k) Device
DEKA LOTUS | Reference Device
K202503
QUANTA Chrome
IPL 570-1200 nm | Comments |
|--------------------------------------|--------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Product code and
regulation | ONF
21 CFR 878.4810 | GEX
21 CFR 878.4810 | Predicate device
includes laser
handpiece while the
subject device has
only IPL. |
| Pulsed light
Emission
spectrum | 570 - 1200 nm | 570 - 1200 nm | Identical |
| Fluence | Up to 25 J/cm² | Up to 25 J/cm² | Identical |
| Spot Size | 20x17 mm | 48x13 mm
25x13mm | Similar |
| Pulse Duration | Up to 40 ms | Up to 40 ms | Identical |
| Repetition Rate | 3 Hz max. | 3 Hz max. | Identical |
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500G Pulsed light handpiece
| Comments | |||
|---|---|---|---|
| Device Trade | Proposed 510(k) Device | Predicate 510(k) Device | |
| Name | DEKA LOTUS | DEKA LOTUS | |
| Indications for | |||
| Use | Intended for treatment of benign | ||
| pigmented lesions, including | |||
| lentigines, nevi, melasma, and | |||
| cafe-au-lait; and treatment of | |||
| benign vascular lesions, including | |||
| port wine stains, hemangiomas, | |||
| angiomas, telangiectasias, | |||
| rosacea, facial and leg veins. | Intended for treatment of benign | ||
| pigmented lesions, including | |||
| lentigines, nevi, melasma, and | |||
| cafe-au-lait; and treatment of | |||
| benign vascular lesions, including | |||
| port wine stains, hemangiomas, | |||
| angiomas, telangiectasias, | |||
| rosacea, facial and leg veins. | Identical | ||
| Product code | |||
| and regulation | ONF | ||
| 21 CFR 878.4810 | ONF | ||
| 21 CFR 878.4810 | Identical | ||
| Pulsed light | |||
| Emission | |||
| spectrum | 500-670nm, 870-1200 nm | 500-670nm, 870-1200 nm | Identical |
| Fluence | Up to 80 J/cm² | Up to 80 J/cm² | Identical |
| Spot Size | 17x20 mm | 17x20 mm | Identical |
| Pulse Duration | 1-100 ms | 1-100 ms | Identical |
| Repetition Rate | 1 Hz max. | 1 Hz max. | Identical |
RF handpiece
| | Device Trade
Name | Proposed 510(k) Device | Predicate 510(k) Device | Comments |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----------|
| | DEKA LOTUS | DEKA LOTUS | | |
| Indications for Use | Intended for use in
dermatologic and general
surgical procedures for the non-
invasive treatment of mild to
moderate facial wrinkles and
rhytides | Intended for use in
dermatologic and general
surgical procedures for the non-
invasive treatment of mild to
moderate facial wrinkles and
rhytides | Identical | |
| Product code and
regulation | GEI
21 CFR. 878.4400 | GEI
21 CFR. 878.4400 | Identical | |
| Energy source | RF (bipolar) | RF (bipolar) | Identical | |
| Frequency | 1 MHz | 1 MHz | Identical | |
8
| Device Trade | Proposed 510(k) Device | Predicate 510(k) Device | Comments |
|---|---|---|---|
| Name | DEKA LOTUS | DEKA LOTUS | |
| Waveform | Sinusoidal | Sinusoidal | Identical |
| Applicator type | Bipolar RF, 3 electrodes | Bipolar RF, 3 electrodes | Identical |
| Maximum output | |||
| power | 50W on 2000hm (large tip) | ||
| 15W on 2000hm (medium tip) | 50W on 2000hm (large tip) | ||
| 15W on 2000hm (medium tip) | Identical | ||
| Output voltage on | |||
| 2000hm | 100V rms | 100V rms | Identical |
| Power delivery | |||
| algorithms | Power regulation by PWM | ||
| modulation, phase rotation | |||
| between electrodes | Power regulation by PWM | ||
| modulation, phase rotation | |||
| between electrodes | Identical | ||
| Electrodes | |||
| diameter | 15 mm (large tip) | ||
| 6 mm (medium tip) | 15 mm (large tip) | ||
| 6 mm (medium tip) | Identical | ||
| Electrodes height | 15 mm (large tip) | ||
| 14 mm (medium tip) | 15 mm (large tip) | ||
| 14 mm (medium tip) | Identical | ||
| Distance between | |||
| electrodes centers | 20 mm (large tip) | ||
| 10 mm (medium tip) | 20 mm (large tip) | ||
| 10 mm (medium tip) | Identical |
Clinical Performance Data:
None.
Non-Clinical Performance Data:
- Test according to IEC 60601-2-57:2011 for the modified IPL Handpiece.
Conclusion:
Based on the comparison of indications for use and the technological characteristics, we can conclude that the DEKA LOTUS device is as safe, as effective, and performs as well as the legally marketed predicate devices K202503, K233473.