(88 days)
No
The document does not mention AI, ML, deep learning, neural networks, or any related terms. The device description focuses on the energy types and applicators, and the performance studies describe standard electrical, safety, and system verification tests.
Yes.
Explanation: The device is intended for the treatment of various medical conditions, including benign pigmented epidermal and cutaneous lesions, benign cutaneous vascular lesions, acne vulgaris, and moderate to severe facial wrinkles and rhytides, which are all therapeutic interventions.
No
The Venus Versa System is described as a multi-application device intended for aesthetic procedures and treatment of various skin conditions, and for hair removal. Its listed "Intended Use / Indications for Use" and "Device Description" primarily discuss delivering energy (IPL, RF, MP2) for therapeutic or cosmetic purposes, not for diagnosing conditions.
No
The device description explicitly states it is comprised of a console (controller/CPU) and ten detachable handpieces (applicators) that deliver energy to the patient's skin. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "aesthetic procedures" and "dermatologic and general surgery procedures" involving the skin. It focuses on treating conditions on the body, not analyzing samples from the body.
- Device Description: The device delivers energy (IPL, RF, MP2) to the patient's skin. This is a therapeutic or aesthetic intervention, not a diagnostic process involving in vitro analysis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is entirely external and procedural.
N/A
Intended Use / Indications for Use
The Venus Versa System is a multi-application device intended to be used in aesthetic procedures. The SR515 and SR580 IPL applicators are indicated for the following:
Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.
Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations.
The HR650, HR690, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris.
The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for the non-invasive treatment of moderate to severe facial wrinkles and rtides in Fitzpatrick skin types I-IV.
The Viva applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.
The Venus Versa System is a multi-application device intended to be used in aesthetic and cosmetic procedures.
The SR515 and SR580 IPL applicators are indicated for the following:
- . Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.
- . Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
The HR650, HR650, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris.
The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV.
The Viva applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Product codes
ONF, GEX
Device Description
The Venus Versa System is comprised of a console (controller/CPU) and ten detachable handpieces (applicators). The system can deliver three types of energies to the patient's skin using the associated applicators:
- Intense Pulsed Light (IPL); ●
- Radiofrequency (RF); .
- Magnetic Pulse (MP2). .
The following ten handpieces are included with the device system: SR515, SR580, HR650, HR690, HR650XL, HR690XL, ACDUAL, Diamondpolar, Octipolar, and Viva.
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
The performance of the Venus Versa has been demonstrated in testing. Electromagnetic Compatibility and Electrical Safety testing was conducted per AAMI/ANSI ES60601-1. IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-57. All results were passing. In addition, the patient contacting materials are biocompatible based on the established biocompatibility of the materials and per ISO 10993-5. The applicable cleaning, disinfection, and sterilization parameters have also been validated in testing.
The Venus Versa System also underwent software validation and results demonstrate that the software was appropriate for release.
System verification testing was performed on the subject Versa System with all 10 of the applicators. Results were all passing. Specifically, the Versa IPL applicators were tested to show that the measured fluence at each wavelength matches the expected value within the defined acceptance criterion. In addition, the light guide temperatures were also measured per the expected values. The measured fluence levels at each wavelength were within the expected values, demonstrating passing results for each applicator. Testing was conducted in increments of 5 J/cm² for a comprehensive evaluation across the range of fluence levels. The fluke measured temperatures of each applicator met specifications.
In addition, as previously submitted in K152790, the Venus Versa IPL applicators SR515, SR580, HR650, and HR690 were evaluated in spectrum testing. The Versa IPL applicators were measured using a spectrometer at each of the wavelengths. At each wavelength, the test results demonstrated that the spectral region is defined by the filter. Further, the ACDUAL applicator spectrum testing was also performed as part of the IEC 60601-2-57 testing.
For the Diamondpolar and Octipolar applicators, system verification testing showed that measured RF voltage, electromagnetic field density, and system temperature were within expected values and met the pass criteria. It should further be noted that the performance of these applicators were previously demonstrated in the company's cleared Legacy BX 510(k) (K142910).
For the Viva applicator, system verification testing showed that the measured output power (pulse width, pulse amplitude) was within expected values. In addition, the performance of the Viva applicator was previously demonstrated in the company's cleared Viva SR System 510(k) (K150161). As detailed in the report, system verification also ensured that the Versa applicators and system met technical and mechanical requirements. All results were passing.
Key Metrics
Not Found
Predicate Device(s)
K060516, K100053, K140668, K142910, K150161
Reference Device(s)
K142860, K141237, K072564, K123257, K053628, K150051, K122995, K041086, K113018
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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping heads suggesting community and connection. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2016
Venus Concept Ltd. % Janice Hogan Regulatory Counsel Hogan Lovells Us Llp 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K153717
Trade/Device Name: Venus Versa System 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. GEX Dated: December 24, 2015 Received: December 24, 2015
Dear Ms. Hogan:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153717
Device Name Venus Versa System
Indications for Use (Describe)
The Venus Versa System is a multi-application device intended to be used in aesthetic procedures. The SR515 and SR580 IPL applicators are indicated for the following:
Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.
Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations.
The HR650, HR690, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris.
The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for the non-invasive treatment of moderate to severe facial wrinkles and rtides in Fitzpatrick skin types I-IV.
The Viva applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.
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
Venus Concept's Venus Versa System
Sponsor/Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Venus Concept USA Ltd. 4556 N. Hiatus Road Sunrise, FL 33351 Telephone: 416.907.0115 Fax: 954.572.5680
Contact Person: Tal Bresler-Stramer, Ph.D., RAC VP QA/RA Venus Concept, Ltd.
Date Prepared: March 18, 2016
Trade Name of Device
Venus Versa System
Classification Regulation, Name, Product Code
Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810), Product Codes: ONF, GEX
Predicate/Reference Devices
Predicate Devices:
Danish Dermatologic Development A/S's Ellipse I-PL System (K060516) MATTIOLI Pulse TWO/THREE Plus Family (K100053) Global Medical Technology S.L.'s Platinum GMT IPL System Cloud (K140668) Venus Concept Ltd.'s Venus Legacy BX Device (K142910) Venus Concept Ltd.'s Viva SR Device (K150161)
Reference Devices:
Lumenis M22 System (K142860); Alma Laser's Harmony Lite Multi-Application Platform (K141237, K072564); Emvera Diolux (K123257); Lumenis Inc.'s LightSheer Duet Laser System (K053628); BTL's Exilite IPL system (K150051); Beijing KES Biology Technology's IPL System (K122995); Palomar Medical Products, Inc.'s StarLux Pulsed Light System (K041086); Beijing Syntech Laser Co.'s APOLLO V+ (K113018)
Intended Use / Indications for Use
The Venus Versa System is a multi-application device intended to be used in aesthetic and cosmetic procedures.
The SR515 and SR580 IPL applicators are indicated for the following:
4
- . Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.
- . Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
The HR650, HR650, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris.
The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV.
The Viva applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Device Description
The Venus Versa System is comprised of a console (controller/CPU) and ten detachable handpieces (applicators). The system can deliver three types of energies to the patient's skin using the associated applicators:
- Intense Pulsed Light (IPL); ●
- Radiofrequency (RF); .
- Magnetic Pulse (MP2). .
The following ten handpieces are included with the device system: SR515, SR580, HR650, HR690, HR650XL, HR690XL, ACDUAL, Diamondpolar, Octipolar, and Viva.
Technological Characteristics
The Venus Versa System has similar technological characteristics to its predicates. The Versa is a multi-application system that allows delivery of energy, similar to its predicates. The Versa and the predicate devices are each designed as a system console with a user interface and applicator(s) indicated for the desired treatment effects. The technological characteristics of the Venus Versa as a system and when used for each of the proposed indications (vascular lesions, pigmented lesions, hair removal/reduction, acne) are similar to the corresponding parameters of the predicate devices. The technological differences between the Venus Versa and its predicates are minor, including some minor differences in terms of the spot size, frequency, and pulse duration. However, the key parameters of the Versa affecting treatment outcomes (i.e., wavelengths, fluence levels, total energy) are the same or encompassed within the range of the predicate devices. Therefore, the dimensional differences or other technical differences between the Versa and its predicates do not present any new or different issues of safety or effectiveness. Therefore, the Venus Versa
5
System presents similar technological characteristics as its predicates, in support of
substantial equivalence. See Table 1 below.
6
Table 1. Venus Concept, Ltd.'s Venus Versa Substantial Equivalence Charts
| Substantial Equivalence Table #1 for IPL Applicators: (1) SR515; (2) SR580; (3) HR650; (4) HR690; (5)HR650XL; (6) HR690XL; (7) |
|---|
| ACDUAL |
| Medical
Device | Venus Concept Ltd.'s
Venus Versa System –
Full Configuration | Danish Dermatologic
Development A/S Ellipse
I²PL System (K060516) | Mattioli Pulse TWO/THREE
Plus Family (K100053) | Global Medical Technology
S.L.'s Platinum GMT IPL
System Cloud (K140668) |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class,
Product
Code,
Regulation | Class II
ONF, GEX
21 CFR 878.4810 | Class II, GEX, 21 CFR
878.4810 | Class II, ONF, 21 CFR
878.4810 | Class II, ONF, 21 CFR
878.4810 |
| Intended
Use /
Indications
for Use | The Venus Versa System is
a multi-application device
intended to be used in
aesthetic and cosmetic
procedures.
The SR515 and SR580 IPL
applicators are indicated for
the following:
• Treatment of benign
pigmented epidermal and
cutaneous lesions including:
hyperpigmentation,
melasma, ephelides
(freckles), lentigines, nevi,
and cafe-au-lait macules.
• Treatment of benign
cutaneous vascular lesions
including port wine stains,
hemangiomas, facial,
truncal and leg
telangiectasias, rosacea,
angiomas and spider
angiomas, poikiloderma of
civatte, leg veins and
venous malformations. | Ellipse I²PL System is
intended for use in
dermatology:
- Hair removal (permanent
hair reduction). - Treatment of benign
pigmented lesions (including,
but not limited to solar
lentigines, ephilides, mottled
pigmentation) and benign
vascular lesions (including
but not limited to diffuse
redness, telangiectasias, port
wine stains). - Treatment of inflammatory
acne.
[Table included in indications
for use form not included
here, see Appendix 4 of
510(k)] | The MATTIOLI PULSE
TWO/THREE PLUS is an
Intense Pulse Light (IPL)
device family indicated for
use in aesthetic applications
(based on selective
photothermolysis), in the
treatment of various benign
pigmented lesions and hair
removal and that produce
different effects depending
on the applicator that is
used:
SA APPLICATOR:
Model SN: Wavelengths
from 560 - 1200 nm are
indicated for treatment of
benign pigmented (epidermal
and cutaneous) lesions,
including hyperpigmentation,
warts, lentigines, nevi,
melasma, and cafe-au-lait.
VA APPLICATOR | The Platinum GMT™ IPL
System Cloud device
(inclusive of the hand piece
used to deliver pulsed-light
energy) is indicated for use
in surgical, aesthetic and
cosmetic applications in
permanent hair reduction,
moderate inflammatory acne
vulgaris, benign cutaneous
pigmented and vascular
lesions.
Permanent hair reduction is
defined as the long-term
stable reduction in the
number of hairs regrowing
when measured at 6, 9, and
12 months after the
completion of a treatment
regimen. |
| Medical
Device | Venus Concept Ltd.'s
Venus Versa System –
Full Configuration | Danish Dermatologic
Development A/S Ellipse
I²PL System (K060516) | Mattioli Pulse TWO/THREE
Plus Family (K100053) | Global Medical Technology
S.L.'s Platinum GMT IPL
System Cloud (K140668) |
| | The HR650, HR690,
HR650XL, and HR690XL
IPL applicators are indicated
for the removal of unwanted
hair and to effect stable
long-term or permanent hair
reduction for skin types I-IV.
Permanent hair reduction is
defined as the long-term
stable reduction in the
number of hairs regrowing
when measured at 6, 9, and
12 months after the
completion of a treatment
regimen.
The Venus Concept
ACDUAL applicator is
intended to be used for the
treatment of acne vulgaris. | | Model VN: Wavelengths
from 510 - 1200 nm are
indicated for the treatment of
benign vascular lesions
including port wine stains,
hemangiomas, facial, truncal
and leg telangiectasias,
rosacea, melasma,
angiomas and spider
anglormas, poikiloderma of
civatte; leg veins, facial veins
and venous malformations.
HR APPLICATORS
indicated for the treatment of
unwanted hair (i.e. hair
removal).
Model HN: Wavelengths
from 650-1200 nm for skin
types I-IV;
Model HF: Wavelengths from
710 - 1200 nm for skin type
V
The equipment should only
be used under medical
supervision. | |
| Energy Type | IPL | IPL | IPL | IPL |
| IPL
Spectrum | - Lesions: 515-950 nm
(SR515); 580-950 nm
(SR580)
- Hair Removal: 650-950
nm (HR650, HR650XL);
690-950 nm (HR690,
HR690XL) | 400-950 - Lesions:
▪ Pigmented: 400-720 nm
(PL)
▪ Vascular: 555-950 nm
(VL); 530-750 nm (PR)
Hair Removal: 600-950nm | 510-1200 nm - Lesions: 560-1200 nm
(SA); 510-1200 nm (VA) - Hair Removal: 650-1200
nm (HN); 710-1200 nm
(HF) | 430-1200 nm - Lesions: 560-1200 nm
▪ Pigmented: 560-1200
nm
▪ Vascular: 560-1200 nm - Hair reduction: 695-1200 |
| Medical
Device | Venus Concept Ltd.'s
Venus Versa System –
Full Configuration | Danish Dermatologic
Development A/S Ellipse
I²PL System (K060516) | Mattioli Pulse TWO/THREE
Plus Family (K100053) | Global Medical Technology
S.L.'s Platinum GMT IPL
System Cloud (K140668) |
| - Acne: 415 - 480 nm
and 630 - 950 nm
(ACDUAL) | | (HR, HR-S); 645-950 nm
(HR-D) | | nm - Acne: 430-1200 nm |
| Frequency | Up to 3 Hz (SR, HR, HR XL)
Up to 2 Hz (ACDUAL) | 1.5-2.0 s charge
time/repetition rate | Up to 1 Hz | 1s, 2s, 3s repetition
frequency |
| Spot Size | 10 x 30 mm (SR 515, SR
580, HR650, HR690,
ACDUAL)
20 x 30 mm (HR650XL,
HR690XL) | 10 x 48 mm | 10 x 40 mm
15 x 50 mm | 10 x 45 mm
8 x 34 mm |
| Pulse
Duration | 5-20 ms (SR515, SR580,
ACDUAL); 20-50 ms
(HR650, HR690, HR650XL,
HR690XL). | 1.5-100 ms | 14-35 ms | 1-9.9 ms - Lesions:
■ Pigmented: 3-9 ms
▪ Vascular: 9.9 ms
o Hair reduction: 9.9 ms
Acne: 3-8 ms |
| Energy
Density
(Fluence) | Lesions/Acne (SR 515, SR
580, ACDUAL):
5-25 J/cm²
Hair Removal (HR650,
HR690, HR650XL,
HR690XL): 5-20 J/cm² | Max 26 J/cm² - Lesions:
■ Pigmented: up to 18
J/cm²
■ Vascular: up to 26 J/cm²
Hair Removal: up to 21
J/cm² | Max 30 J/cm² - Skin Rejuvenation (SR):
6-30 J/cm² - Hair Removal (HR): 6-25
J/cm² | Max 60 J/cm² - Lesions:
■ Pigmented: 12-44 J/cm²
▪ Vascular: 10-50 J/cm² - Hair reduction: 10-60
J/cm² - Acne: 10-40 J/cm² |
| Components | System console (with user
interface)
Applicators
Ultrasonic gel | System console (with user
interface)
Applicators
Optical coupling gel | System console (with user
interface)
Applicators | System console (with user
interface)
Applicators |
| Light guide | Sapphire light guide | Light guide | Crystal Light Guide | Sapphire light guide |
| Cooling
system | Cooling system | Cooling system | Cooling system | Cooling system |
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8
9
Substantial Equivalence Table #2 for Bipolar RF and PMF Applicators: (1) Diamondpolar; (2) Octipolar
| Medical Device | Venus Concept Ltd.'s
Diamondpolar and Octipolar
Applicators | Venus Concept Ltd.'s Venus Legacy BX
Device (K142910) |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class, Product Code,
Regulation | Class II, GEI, 21 CFR 878.4400 | Class II, GEI, 21 CFR 878.4400 |
| Intended Use / Indications
for Use | The Diamondpolar and Octipolar
applicators are non-invasive devices
intended for use in dermatologic and
general surgery procedures for females
for the non-invasive treatment of
moderate to severe facial wrinkles and
rhytides in Fitzpatrick skin types I-IV. | The device is a non-invasive device
intended for use in dermatologic and
general surgery procedures for females for
the non-invasive treatment of moderate to
severe facial wrinkles and rhytides in
Fitzpatrick skin types I-IV |
| Energy Type | Bipolar RF, PMF | Bipolar RF, PMF |
| Applicators | Diamondpolar
Octipolar | Diamondpolar
Octipolar |
| Maximum RF Output Power | Diamondpolar: 75 W
Octipolar: 150 W | Diamondpolar: 75 W
Octipolar: 150 W |
| RF Output Frequency | 1 MHz | 1 MHz |
| Magnetic Pulse Frequency | 15 Hz | 15 Hz |
| Magnetic Field | Up to 15 Gauss | Up to 15 Gauss |
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Substantial Equivalence Table #3 for Fractional RF Applicator: (1) Viva
| Medical Device | Venus Concept Ltd.'s
Viva Applicator | Venus Concept Ltd.'s Viva SR Device
(K150161) |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Class, Product Code,
Regulation | Class II, GEI, 21 CFR 878.4400 | Class II, GEI, 21 CFR 878.4400 |
| Intended Use / Indications for
Use | The Viva applicator is intended for
dermatological procedures requiring
ablation and resurfacing of the skin. | The Venus Viva SR System is intended for
dermatological procedures requiring ablation
and resurfacing of the skin. |
| Energy Type | Fractional RF | Fractional RF |
| (Maximum) RF Energy | 62 mJ/pin | 62 mJ/pin |
| Maximum RF Output Power | 8 W | 8 W |
| Applicator | Viva | Viva |
| Number of Pins | 40 x 4 = 160 pins | 40 x 4 = 160 pin |
| RF Output Frequency | 0.46 MHz | 0.46 MHz |
| Contact Area of Pin/ Active
Area | 133 mm² | 133 mm² |
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Performance Data and Standards
The performance of the Venus Versa has been demonstrated in testing. Electromagnetic Compatibility and Electrical Safety testing was conducted per AAMI/ANSI ES60601-1. IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-57. All results were passing. In addition, the patient contacting materials are biocompatible based on the established biocompatibility of the materials and per ISO 10993-5. The applicable cleaning, disinfection, and sterilization parameters have also been validated in testing.
The Venus Versa System also underwent software validation and results demonstrate that the software was appropriate for release.
System verification testing was performed on the subject Versa System with all 10 of the applicators. Results were all passing. Specifically, the Versa IPL applicators were tested to show that the measured fluence at each wavelength matches the expected value within the defined acceptance criterion. In addition, the light guide temperatures were also measured per the expected values. The measured fluence levels at each wavelength were within the expected values, demonstrating passing results for each applicator. Testing was conducted in increments of 5 J/cm² for a comprehensive evaluation across the range of fluence levels. The fluke measured temperatures of each applicator met specifications.
In addition, as previously submitted in K152790, the Venus Versa IPL applicators SR515, SR580, HR650, and HR690 were evaluated in spectrum testing. The Versa IPL applicators were measured using a spectrometer at each of the wavelengths. At each wavelength, the test results demonstrated that the spectral region is defined by the filter. Further, the ACDUAL applicator spectrum testing was also performed as part of the IEC 60601-2-57 testing.
For the Diamondpolar and Octipolar applicators, system verification testing showed that measured RF voltage, electromagnetic field density, and system temperature were within expected values and met the pass criteria. It should further be noted that the performance of these applicators were previously demonstrated in the company's cleared Legacy BX 510(k) (K142910).
For the Viva applicator, system verification testing showed that the measured output power (pulse width, pulse amplitude) was within expected values. In addition, the performance of the Viva applicator was previously demonstrated in the company's cleared Viva SR System 510(k) (K150161). As detailed in the report, system verification also ensured that the Versa applicators and system met technical and mechanical requirements. All results were passing.
Therefore, performance testing confirmed the equivalent technological characteristics and energy output available for the Versa compared to its predicate.
Substantial Equivalence
The Venus Versa has the same intended use and the same or similar indications for use, technological characteristics and principles of operation as its predicate devices. The technological differences between the Venus Versa and its predicates are minor, including
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some differences in terms of the spot size, frequency, and pulse duration. As detailed above, the minor technological differences between the Venus Versa and its predicate devices do not raise any new types of safety or effectiveness questions, given that the key energy parameters (i.e., wavelengths, fluence levels, total energy) are the same or similar for the devices. Therefore, the Venus Versa System presents similar technological characteristics as its predicates, in support of substantial equivalence.
Conclusions
The Venus Versa has the same intended use and the same or similar indications for use, technological characteristics and principles of operation as its predicate devices. Testing demonstrates that the device performs as intended for the indicated uses of each applicator. Minor differences between the subject and predicate devices do not present any new or different types of safety or effectiveness questions, as confirmed by device performance evaluations. In sum, the Venus Versa System is substantially equivalent to its predicate devices.