(117 days)
No
The summary does not mention any terms related to AI or ML, nor does it describe functionalities that typically rely on these technologies. The device description focuses on hardware and basic control parameters.
No.
The device is indicated for aesthetic procedures such as hair removal and treatment of skin lesions (hyperpigmentation, melasma, vascular lesions), which are generally not considered therapeutic in the medical sense as they typically address cosmetic concerns rather than disease treatment or prevention.
No
The device is described as a multi-application device for aesthetic procedures, treating conditions like pigmented and vascular lesions and removing unwanted hair by delivering IPL energy. It does not mention any function for identifying or determining the nature of a disease or condition, which would be characteristic of a diagnostic device.
No
The device description explicitly states it is comprised of a console (controller/CPU) and applicators that deliver Intense Pulsed Light (IPL) optical energy, indicating it is a hardware system with integrated software.
Based on the provided information, the Venus Versa System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used in "aesthetic procedures" and for treating various "benign pigmented epidermal and cutaneous lesions" and "benign cutaneous vascular lesions," as well as "removal of unwanted hair." These are all procedures performed directly on the patient's body.
- Mechanism of Action: The device delivers "Intense Pulsed Light (IPL) optical energy to the treatment area" on the patient's skin.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information. IVD devices are specifically designed for testing samples in vitro.
Therefore, the Venus Versa System is a therapeutic device used for aesthetic and dermatological treatments, not an IVD device.
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 and HR690 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 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.
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
The Venus Versa System is comprised of a console (controller/CPU) and applicators that deliver Intense Pulsed Light (IPL) optical energy to the treatment area. Four IPL handpieces (SR515, SR580, HR650, HR690) are included with the device system. The Versa device provides individual adjustment of light fluency and pulse duration, and has integrated skin cooling features. Using the IPL applicators, the light energy delivered to the patient's skin is used to treat various conditions via the mechanism of selective photothermolysis.
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)
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, and IEC 60601-2-57. All results were passing. In addition, the patient contacting materials are biocompatible per ISO 10993-5. Cleaning and disinfection validation testing has also been completed.
The Venus Versa System also underwent software validation and results demonstrate that the software was appropriate for release. Bench testing further confirmed that the energy outputs of the Versa met specifications.
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.
K141237, K123257, K053628, K143554, K041086, K122995, K150051, K113018, K113868, K142376, K063427
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2016
Venus Concept Ltd. % Ms. Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th FL Philadelphia, Pennsylvania 19103
Re: K152790
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 Dated: December 21, 2015 Received: December 21, 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 -S
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) K152790
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 and HR690 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 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.
| 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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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: December 21, 2015
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 Code: ONF
Predicate and Reference Devices
Predicate Devices: Danish Dermatologic Development A/S's Ellipse I PL System (K060516) (Primary Predicate), MATTIOLI Pulse TWO/THREE Plus Family (K100053)
Reference Devices: Alma Laser's Harmony Lite Multi-Application Platform (K141237); Emvera Diolux (K123257); Lumenis Inc.'s LightSheer Duet Laser System (K053628); Venus Legacy CX (K143554); Palomar Medical Products, Inc.'s StarLux Pulsed Light System (K041086); Beijing KES Biology's IPL System (K122995); BTL Industries, Inc.'s Exilite (K150051); Beijing Syntech Laser Co.'s APOLLO V+ (K113018); Syneron's ePlus Treatment System (K113868); Cynosure's Icon (K142376); Lynton Lumina (K063427)
Intended Use / Indications for Use
The Venus Versa System is a multi-application device intended to be used in aesthetic and cosmetic procedures.
4
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 and HR690 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.
Device Description
The Venus Versa System is comprised of a console (controller/CPU) and applicators that deliver Intense Pulsed Light (IPL) optical energy to the treatment area. Four IPL handpieces (SR515, SR580, HR650, HR690) are included with the device system. The Versa device provides individual adjustment of light fluency and pulse duration, and has integrated skin cooling features. Using the IPL applicators, the light energy delivered to the patient's skin is used to treat various conditions via the mechanism of selective photothermolysis.
Technological Characteristics
The Venus Versa System has similar technological characteristics to its predicates. All three devices are IPL systems requlated under 21 CFR 878.4810 as class II devices. The Versa is a multi-application system that allows delivery of IPL enerqy, 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 three proposed indications (vascular lesions, pigmented lesions, hair removal/reduction) are similar to the corresponding parameters of the predicate devices. The technological differences between the Venus Versa and its predicates are minor, including some differences in terms of the spot size, frequency, and pulse duration. However, the kev parameters of the Versa affecting treatment outcomes (i.e., IPL wavelengths, fluence levels) are the same or encompassed within the range of the predicate devices. In addition, each of the systems utilizes a light quide and cooling system in delivering treatment. See Table 1 below.
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| Medical Device | Venus Concept Ltd.'s Venus Versa
System (K152790) | Danish Dermatologic Development A/S
Ellipse I²PL System (K060516) | Mattioli Pulse TWO/THREE Plus Family
(K100053) |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class, Product
Code, Regulation | Class II, ONF, 21 CFR 878.4810 | Class II, GEX, 21 CFR 878.4810 | Class II, ONF, 21 CFR 878.4810 |
| 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.
The HR650 and HR690 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. | 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.] | 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
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
angiomas, 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 HE: Wavelengths from 710 - 1200 |
Table 1: Venus Versa System Substantial Equivalence Comparison
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| Medical Device | Venus Concept Ltd.'s Venus Versa
System (K152790) | Danish Dermatologic Development A/S
Ellipse I²PL System (K060516) | Mattioli Pulse TWO/THREE Plus Family
(K100053) |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| | | | nm for skin type V
The equipment should only be used under
medical supervision. |
| Energy Type | IPL | IPL | IPL |
| IPL Spectrum | 515-950 nm
o Lesions: 515-950 nm (SR515); 580-
950 nm (SR580)
▪ Pigmented Lesions: 515-950 nm
(SR515); 580-950 nm (SR580)
▪ Vascular Lesions: 515-950 nm
(SR515); 580-950 nm (SR580)
o Hair Removal: 650-950 nm (HR650);
690-950 nm (HR690) | 400-950
o Lesions:
▪ Pigmented Lesions: 400-720 nm
(PL)
▪ Vascular Lesions: 555-950 nm (VL);
530-750 nm (PR)
o Hair Removal: 600-950nm (HR, HR-S);
645-950 nm (HR-D) | 510-1200 nm
o Lesions: 560-1200 nm (SA); 510-1200
nm (VA)
o Hair Removal: 650-1200 nm (HN);
710-1200 nm (HF) |
| Frequency | Up to 3 Hz | 1.5-2.0 s charge time/repetition rate | Up to 1 Hz |
| Spot Size | 10 x 30 mm | 10 x 48 mm | 10 x 40 mm
15 x 50 mm |
| Pulse Duration | Up to 50 ms
o Lesions (SR515, SR580): 5-20 ms
▪ Pigmented Lesions: 10-20 ms
▪ Vascular Lesions: 10-20 ms
o Hair Removal (HR650, HR690): 20-50
ms | 1.5-100 ms | 14-35 ms |
| Energy Density
(Fluence) | Up to 25 J/cm²
o Lesions:
▪ Pigmented Lesions: 5-20 J/cm²
▪ Vascular Lesions: 6-22 J/cm²
o Hair Removal: 6-20 J/cm² | Up to 26 J/cm²
o Lesions:
▪ Pigmented Lesions: up to 18 J/cm²
▪ Vascular Lesions: up to 26 J/cm²
o Hair Removal: up to 21 J/cm² | Up to 30 J/cm²
o Skin Rejuvenation (SR): 6-30 J/cm²
o Hair Removal (HR): 6-25 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 |
| Light guide | Sapphire light guide | Light guide | Crystal Light Guide |
| Cooling system | Cooling system | Cooling system (circulating water) | Cooling system (water cooling) |
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Therefore, the dimensional differences and other minor technological differences between the Versa and its predicates do not present any new or different issues of safety or effectiveness. Therefore, the Venus Versa System presents similar technological characteristics as its predicates, in support of substantial equivalence.
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, and IEC 60601-2-57. All results were passing. In addition, the patient contacting materials are biocompatible per ISO 10993-5. Cleaning and disinfection validation testing has also been completed.
The Venus Versa System also underwent software validation and results demonstrate that the software was appropriate for release. Bench testing further confirmed that the energy outputs of the Versa met specifications.
Substantial Equivalence
The Venus Versa has the same intended use and similar indications for use, technological characteristics and principles of operation as its predicate devices. The minor technological differences between the Venus Versa and its predicate devices do not raise any new or different issues of safety or effectiveness, given that the key energy parameters are the same or similar for the devices.
Conclusions
The tests outlined above demonstrate 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.