(91 days)
Not Found
No
The document describes a laser system with standard components and user-controlled settings. There is no mention of AI, ML, or any features that would suggest automated decision-making or learning from data.
Yes.
The device's intended use is to treat various medical conditions, including benign vascular lesions, benign cutaneous lesions, and wrinkles, by delivering laser energy. This indicates a therapeutic purpose.
No
The device is described as a laser system intended for the coagulation and hemostasis of various benign vascular and cutaneous lesions, as well as the treatment of wrinkles. Its purpose is therapeutic (treatment), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states it is comprised of hardware components including a main console, power supply, cooling system, and handpieces, in addition to software and firmware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Vbeam Prima Laser System is a medical device that delivers laser energy to the skin for the treatment of various benign vascular and cutaneous lesions, as well as wrinkles. It is a therapeutic device that acts directly on the patient's body.
- Lack of In Vitro Testing: The description of the device and its intended use does not involve any testing of samples taken from the body. The laser is applied externally to the skin.
Therefore, the Vbeam Prima Laser System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
1,064nm:
The Vbeam Prima Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait manules, sebortheic keratoses, nevi, chloasma, verrucea, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
595 nm:
General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia. rosacea, port wine stains, hemangioma, spider angioma, poikiloderma of civatte, and benign cutaneous lesions, such as warts, scars, striae, psoriasis and the treatment of benign epidermal pigmented lesions. Treatment of inflammatory acne vulgaris.
Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
Podiatry: Treatment of benign cutaneous lesions, such as warts.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Vbeam Prima Laser system is designed as a transportable device that delivers laser energy at wavelengths of 595 nm (pulse-dye) or 1064 nm (Nd: YAG). The device is comprised of a main console, power supply, controlled electronics, firmware, software, cooling system, and handpieces. There is also an internal calibration port with an internal meter located in the system. The handpiece offers a set of distance gauges available in the following spot ranges: 3-7 mm, 7-11 mm, 11-15 mm, and 3 X 10 mm. The user selects treatment settings, such as fluence, number of pulses, and spot size selection via a color touch screen. The handpiece incorporates a Dynamic Cooling Device (DCD) into its handpiece that is designed to cool the skin surface during treatment, which consists of an electrically controlled spray nozzle, cryogen reservoir canister and an electronic control circuitry. The Vbeam Prima Laser System also offers an optional EverCool Delivery System Handpiece for skin cooling during treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 following performance data was included in the 510(k) Premarket Notification to support the substantial equivalence determination:
Electrical Safety and Electromagnetic Compatibility:
The device passed the required testing and is in full compliance with the standards:
- IEC 60825-1: Safety of Laser Products – Part 1: Equipment classification and requirements
- IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for safety - collateral standard: electromagnetic compatibility (EMC)requirements and test
- IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- 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
Biocompatibility:
The biocompatibility of the Vbeam Prima Laser System has been established based on the predicate devices and the results of ISO 10993-5 and ISO 10993-10 series of testing.
Software Verification & Validation:
Software verification and validation testing was conducted and results demonstrated that testing results were found acceptable for software release. Software testing was performed per FDA's guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
Bench Testing:
A bench study was conducted to confirm that the DCD handpiece and Evercool handpiece can produce similar cooling results.
Clinical Testing:
Based on the similarities of the device specifications, intended use, indications for use between the Vbeam Prima Laser System and its predicate devices, no clinical studies were needed to support this 510(k) Premarket Notification.
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.
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 5, 2018
Syneron-Candela Sharon Timberlake VP, Global Regulatory and Clinical Affairs 530 Boston Post Road Wayland, Massachusetts 01778
Re: K180593
Trade/Device Name: Vbeam Prima Laser 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: GEX Dated: March 2, 2018 Received: March 6, 2018
Dear Sharon Timberlake:
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, 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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Page 2 - Sharon Timberlake
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer R. Stevenson -S3
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
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Indications for Use
510(k) Number (if known)
Device Name Vbeam Prima Laser System
Indications for Use (Describe)
1,064nm:
The Vbeam Prima Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait manules, sebortheic keratoses, nevi, chloasma, verrucea, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
595 nm:
General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia. rosacea, port wine stains, hemangioma, spider angioma, poikiloderma of civatte, and benign cutaneous lesions, such as warts, scars, striae, psoriasis and the treatment of benign epidermal pigmented lesions. Treatment of inflammatory acne vulgaris.
Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
Podiatry: Treatment of benign cutaneous lesions, such as warts.
| 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 Vbeam® Prima Laser System
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92
1. DATE PREPARED
March 1, 2018
2. APPLICANT NAME
Candela Corporation 530 Boston Post Road Wayland, MA 01778 P: (508) 358-0304 M: (617) 957-1434
3. OFFICIAL CORRESPONDENT
Sharon Timberlake, MSHS, RAC, CCRA VP, Global Clinical & Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, MA 01778 P: (508) 358-0304 M: (617) 957-1434 sharont@syneron-candela.com
4. DEVICE INFORMATION
| Proprietary Name: | Vbeam® Prima Laser System |
|---|---|
| Common/Usual Name: | Pulse Dye and Nd: YAG Laser |
| Classification Name: | Laser surgical instrument for use in General and Plastic |
| surgery and in dermatology (21 CFR Section 878.4810) | |
| Product Code: | GEX |
| Device Classification: | Class 2 |
| Laser Classification: | Class IV |
5. PREDICATE DEVICE
Candela Family of Pulsed Dye Laser Systems (K050673), primary predicate Cynosure Cynergy Multiplex Laser (K050779), additional predicate
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6. INTENDED USE
1,064 nm:
The Vbeam® Prima Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait manules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, and keratoses.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
595 nm:
General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and Psoriasis and the treatment of wrinkles. Treatment of Benign Epidermal Pigmented Lesions.
Treatment of Inflammatory Acne Vulgaris.
Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
Podiatry: Treatment of benign cutaneous lesions, such as warts.
7. DEVICE DESCRIPTION
The Vbeam Prima Laser system is designed as a transportable device that delivers laser energy at wavelengths of 595 nm (pulse-dye) or 1064 nm (Nd: YAG). The device is comprised of a main console, power supply, controlled electronics, firmware, software, cooling system, and handpieces. There is also an internal calibration port with an internal meter located in the system. The handpiece offers a set of distance gauges available in the following spot ranges: 3-7 mm, 7-11 mm, 11-15 mm, and 3 X 10 mm. The user selects treatment settings, such as fluence, number of pulses, and spot size selection via a color touch screen. The handpiece incorporates a Dynamic Cooling Device (DCD) into its handpiece that is designed to cool the skin surface during treatment, which consists of an electrically controlled spray nozzle, cryogen reservoir canister and an electronic control circuitry. The Vbeam Prima Laser System also offers an optional EverCool Delivery System Handpiece for skin cooling during treatment.
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8. TECHNOLOGICAL CHARACTERISTICS
The Vbeam Prima Laser System has the same design, technological characteristics, operating principles, and intended use as the Candela Family of Pulsed Dye Laser Systems (K050673) and the Cynosure Cynergy Multiplex Laser (K050779). The devices all share the same technical features, such as calibration port, wavelengths, laser medium, delivery systems, power supply, cooling system, electronics, firmware, software and user display screen. The devices all share the same operating principles, such as energy, repetition rate, and offer a range of spot sizes. Any minor differences do not raise any new types of safety or effectiveness questions because the Vbeam Prima Laser System parameters are the same as the predicates.
9. PERFORMANCE DATA
The following performance data was included in the 510(k) Premarket Notification to support the substantial equivalence determination:
Electrical Safety and Electromagnetic Compatibility:
Electrical safety and electromagnetic compatibility testing of Epic Pro 940 was conducted according to the recognized standards. The device passed the required testing and is in full compliance with the standards:
- . IEC 60825-1: Safety of Laser Products – Part 1: Equipment classification and requirements
- . IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for safety - collateral standard: electromagnetic compatibility (EMC)requirements and test
- . IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- . 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
Biocompatibility
The biocompatibility of the Vbeam Prima Laser System has been established based on the predicate devices and the results of ISO 10993-5 and ISO 10993-10 series of testing.
Software Verification & Validation
Software verification and validation testing was conducted and results demonstrated that testing results were found acceptable for software release. Software testing was performed per FDA's guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
6
Bench Testing
A bench study was conducted to confirm that the DCD handpiece and Evercool handpiece can produce similar cooling results.
Clinical Testing
Based on the similarities of the device specifications, intended use, indications for use between the Vbeam Prima Laser System and its predicate devices, no clinical studies were needed to support this 510(k) Premarket Notification.
10. STATEMENT OF SAFETY AND EFFECTIVENESS
The Vbeam Prima Laser System shares a similar design and intended use. Additionally, technological characteristics, including wavelengths, laser mediums, pulse width, spot sizes, energy, cooling systems, and repetition rate are similar between the Vbeam Prima Laser System and its predicate devices. The data presented in this 510(k) Premarket Notification further supports this conclusion since the results did not raise any new safety or efficacy concerns. Therefore, the Vbeam Prima Laser System is substantially equivalent to its predicate devices.