Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 1, 2023 Candela Corporation Danielle Gibboney Sr. Regulatory Affairs Specialist 251 Locke Drive Marlborough, Massachusetts 01752 Re: K230990 Trade/Device Name: Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) 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: April 5, 2023 Received: April 6, 2023 Dear Danielle Gibboney: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Jianting Wang -S Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K230990 Device Name Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) Indications for Use (Describe) Vbeam Prima is indicated for the following: 595 nm · General Surgery: · Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions. · Dermatology/Plastic Surgery: o 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: o Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. · Podiatry: - o Treatment of benign cutaneous lesions, such as warts. - · Pediatric Population o Treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas #### 1064 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, and poikiloderma of Civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), café-au-lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, peri-ocular and peri-oral wrinkles. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ # Indications for Use # K230990 Device Name Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) Indications for Use (Describe) Vbeam Perfecta is indicated for the following: 595 nm · General Surgery: - · Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions. - · Dermatology/Plastic Surgery: o 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: o Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. - · Podiatry: - o Treatment of benign cutaneous lesions, such as warts. - · Pediatric Population Treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Candela logo. The logo features a stylized purple icon to the left of the word "CANDELA" in black, sans-serif font. Below the wordmark is the tagline "Science. Results. Trust." in a smaller, purple, sans-serif font. # 510(k) SUMMARY K230990 Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) This summary of 510(k) submitted in accordance with the requirements of 21 CFR 807.92. # 1. Date Prepared April 5, 2023 # 2. APPLICANT NAME Candela Corporation 251 Locke Drive Marlborough MA 01752 USA # 3. Official Correspondent Danielle Gibboney Sr. Regulatory Affairs Specialist Candela Corporation 251 Locke Drive Marlborough MA 01752 USA Phone: 617-904-3820 Email: danielleq@candelamedical.com #### 4. Product Information Name of Device: Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) Common/Usual Name: Powered Laser Surgical Instrument Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology (per 21 CFR Part 878.4810) Device Classification: Class II (per 21 CFR Part 878.4810) Product Code: GEX {6}------------------------------------------------ # 5. Legally Marketed Predicate Device for Claimed Equivalence: Predicate Device: Vbeam Prima Laser System (K183452) Predicate Device: Candela Family of Pulse Laser Systems (K050673) # 6. Device Description: The Candela Vbeam Family of Pulsed Dye Lasers includes both the Vbeam Prima and Vbeam Perfecta Laser Systems. The Vbeam Prima Laser System has been previously cleared for both port wine stains, and hemangiomas under K183452. The Vbeam Perfecta (Candela Family of Pulse Laser Systems) has been previously cleared for both port wine stains, and hemangiomas under K050673. This 510(k) Premarket Notification is to expand the indications for use for the Candela Vbeam Family of Pulsed Dye Lasers for the Vbeam Prima Laser System and Vbeam Perfecta to include the pediatric population for treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas for the 595 nm wavelength. There is no new technology being introduced than what has been previously cleared Vbeam Prima Laser System under its predicate K183452 and Vbeam Perfecta under its predicate K050673. # 7. INTENDED USE AND INDICATIONS FOR USE: #### Vbeam Prima: Vbeam Prima is indicated for the following: 595 nm - General Surgery: - Photocoagulation of benign cutaneous vascular lesions and benign cutaneous ● lesions. - Dermatology/Plastic Surgery: o - o For treatment of beniqn cutaneous vascular lesions, such as facial and leq 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: ● - Photocoaqulation of benign cutaneous lesions and benign vascular lesions in o gynecology. - Podiatry: ● - o Treatment of benign cutaneous lesions, such as warts. - Pediatric Population ● - Treatment of cutaneous capillary malformations, also known as port wine o stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas {7}------------------------------------------------ #### 1064 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), café-au-lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, peri-ocular and peri-oral wrinkles. #### Vbeam Perfecta: Vbeam Perfecta is indicated for the following: 595 nm - General Surgery: - Photocoagulation of benign cutaneous vascular lesions and benign cutaneous ● lesions. - Dermatoloqy/Plastic Surgery: . - For treatment of benign cutaneous vascular lesions, such as facial and leq o 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 o gynecology. - o Podiatry: - Treatment of benign cutaneous lesions, such as warts. O - . Pediatric Population - Treatment of cutaneous capillary malformations, also known as port wine o stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas # 8. Technological Comparison: The subject device Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) is substantially equivalent and identical in the design, function, and intended use to the Vbeam Prima Laser System under K183452 and Vbeam Perfecta under K050673. The difference between the subject Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) and its predicates is the additional indications for Pediatric Population: Treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas that this Premarket Notification is proposing. The expanded indications between the subject device and its predicates does not raise any new concerns of safety or effectiveness of the device. Thus, based on the information presented in this Premarket Notification, Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) is substantially equivalent to its predicates Vbeam Prima Laser System under K183452 and Vbeam Perfecta under K050673. Please refer to specification comparison tables in Table 1 and Table 2 for comparisons between intended use/indications for use, and technological & biological characteristic comparison below. {8}------------------------------------------------ | Name of Device:<br>510(k)<br>Product Code<br>Device Class | Candela Vbeam Family of<br>Pulsed Dye Lasers (Vbeam<br>Prima)<br>Proposed<br>Not Assigned<br>GEX<br>Class II | Vbeam Prima Laser System<br>Predicate<br>K183452<br>GEX<br>Class II | Vbeam Perfecta Laser System<br>Predicate<br>K050673<br>GEX<br>Class II | |-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use /<br>Indications: | Vbeam Prima is indicated for the<br>following:<br>595 nm:<br>General Surgery:<br>Ο Photocoagulation of<br>benign cutaneous<br>vascular lesions and<br>benign cutaneous<br>lesions.<br>Dermatology/Plastic Surgery:<br>Ο For treatment of benign<br>cutaneous vascular<br>lesions, such as facial<br>and leg telangiectasia,<br>rosacea, port wine<br>stains, hemangiomas,<br>angioma, spider<br>angioma, Poikiloderma of<br>Civatte, and benign<br>cutaneous lesions, such<br>as warts, scars, striae<br>and Psoriasis and the<br>treatment of wrinkles. | Vbeam Prima is indicated for<br>following:<br>595 nm:<br>General Surgery:<br>Ο Photocoagulation of<br>benign cutaneous<br>vascular lesions and<br>benign cutaneous<br>lesions.<br>Dermatology/Plastic Surgery:<br>Ο For treatment of benign<br>cutaneous vascular<br>lesions, such as facial<br>and leg telangiectasia,<br>rosacea, port wine<br>stains, hemangiomas,<br>angioma, spider<br>angioma, Poikiloderma<br>of Civatte, and benign<br>cutaneous lesions, such<br>as warts, scars, striae<br>and Psoriasis and the<br>treatment of wrinkles. | 595 nm:<br>General Surgery:<br>Ο Photocoagulation of benign<br>cutaneous vascular lesions<br>and benign cutaneous<br>lesions.<br>Dermatology/Plastic Surgery:<br>Ο For treatment of benign<br>cutaneous vascular lesions,<br>such as facial and leg<br>telangiectasia, rosacea, port<br>wine stains, hemangiomas,<br>angioma, spider angioma,<br>Poikiloderma of Civatte, and<br>benign cutaneous lesions,<br>such as warts, scars, striae<br>and Psoriasis and the<br>treatment of wrinkles.<br>Ο Treatment of Benign<br>Epidermal Pigmented<br>Lesions.<br>Ο Treatment of Inflammatory<br>Acne Vulgaris. | | Name of Device:<br>510(k)<br>Product Code<br>Device Class | Candela Vbeam Family of<br>Pulsed Dye Lasers (Vbeam Prima)<br>Proposed<br>Not Assigned<br>GEX<br>Class II | Vbeam Prima Laser System<br>Predicate<br>K183452<br>GEX<br>Class II | Vbeam Perfecta Laser System<br>Predicate<br>K050673<br>GEX<br>Class II | | | Treatment of Benign Epidermal Pigmented Lesions. Treatment of Inflammatory Acne Vulgaris. | Treatment of Benign Epidermal Pigmented Lesions. Treatment of Inflammatory Acne Vulgaris. | Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. | | | Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. | Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. | Podiatry: Treatment of benign cutaneous lesions, such as warts. | | | Podiatry: Treatment of benign cutaneous lesions, such as warts. | Podiatry: Treatment of benign cutaneous lesions, such as warts. | | | | Pediatric Population: Treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas 1064 nm | 1064 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 | | | Name of Device:<br>510(k)<br>Product Code<br>Device Class | Candela Vbeam Family of<br>Pulsed Dye Lasers (Vbeam<br>Prima)<br>Proposed<br>Not Assigned<br>GEX<br>Class II | Vbeam Prima Laser System<br>Predicate<br>K183452<br>GEX<br>Class II | Vbeam Perfecta Laser System<br>Predicate<br>K050673<br>GEX<br>Class II | | | and hemostasis of benign<br>vascular lesions such as, but not to lentigos (age spots), solar<br>limited to, port wine stains,<br>hemangiomas, warts,<br>telangiectasia, rosacea, Venus<br>lakes, leg veins, spider veins,<br>and poikiloderma of Civatte and<br>treatment of benign cutaneous<br>lesions such as, but not limited<br>to lentigos (age spots), solar<br>lentigos (sun spots), café-au-lait<br>macules, seborrheic keratoses,<br>nevi, chloasma, verrucae, skin<br>tags, and keratoses. The laser is<br>also indicated for the treatment<br>of wrinkles such as, but not<br>limited to, peri-ocular and peri-<br>oral wrinkles. | lesions such as, but not limited<br>to lentigos (age spots), solar<br>lentigos (sun spots), café-au-lait<br>macules, seborrheic keratoses,<br>nevi, chloasma, verrucae, skin<br>tags, and keratoses. The laser<br>is also indicated for the<br>treatment of wrinkles such as,<br>but not limited to, peri-ocular<br>and peri-oral wrinkles. | | | | Vbeam Perfecta is indicated for<br>the following:<br>595 nm:<br>General Surgery:<br>• Photocoagulation of<br>benign cutaneous<br>vascular lesions and<br>benign cutaneous | | | | Name of Device:<br>510(k)<br>Product Code<br>Device Class | Candela Vbeam Family of<br>Pulsed Dye Lasers (Vbeam<br>Prima)<br>Proposed<br>Not Assigned<br>GEX<br>Class II | Vbeam Prima Laser System<br>Predicate<br>K183452<br>GEX<br>Class II | Vbeam Perfecta Laser System<br>Predicate<br>K050673<br>GEX<br>Class II | | | lesions.<br>Dermatology/Plastic Surgery:<br>• For treatment of benign<br>cutaneous vascular<br>lesions, such as facial<br>and leg telangiectasia,<br>rosacea, port wine<br>stains, hemangiomas,<br>angioma, spider<br>angioma, Poikiloderma of<br>Civatte, and benign<br>cutaneous lesions, such<br>as warts, scars, striae<br>and Psoriasis and the<br>treatment of wrinkles.<br>• Treatment of Benign<br>Epidermal Pigmented<br>Lesions.<br>• Treatment of<br>Inflammatory Acne<br>Vulgaris.<br>Gynecology:<br>• Photocoagulation of<br>benign cutaneous lesions<br>and benign vascular<br>lesions in gynecology. | | | | Name of Device:<br>510(k)<br>Product Code<br>Device Class | Candela Vbeam Family of<br>Pulsed Dye Lasers (Vbeam<br>Prima)<br>Proposed<br>Not Assigned<br>GEX<br>Class II | Vbeam Prima Laser System<br>Predicate<br>K183452<br>GEX<br>Class II | Vbeam Perfecta Laser System<br>Predicate<br>K050673<br>GEX<br>Class II | | | Podiatry:<br>• Treatment of benign<br>cutaneous lesions, such<br>as warts.<br>Pediatric Population:<br>Treatment of cutaneous<br>capillary malformations, also<br>known as port wine stains<br>(PWS), and infantile<br>hemangiomas (IH) / congenital<br>hemangiomas | | | | Similarities/Differences | Identical to Predicate device, but<br>with expanded indications<br>identified in <b>BOLD</b> . | Identical to the subject device,<br>but without the expanded<br>indications. | Identical to the subject device, but<br>without the expanded indications. | | General<br>Specifications | Candela Vbeam Family of Pulsed Dye<br>Lasers (Vbeam Prima, Vbeam Perfecta)<br>Proposed<br>Not Assigned | Vbeam Prima Laser System<br>Predicate<br>K183452 | Vbeam Perfecta<br>Predicate<br>K050673 | | Technical<br>Characteristics | Identical | Identical | Identical | | Wavelength | 595 nm<br>IDENTICAL | 595 nm<br>IDENTICAL | 595 nm<br>IDENTICAL | | | 1064 nm (Vbeam<br>Prima only)<br>IDENTICAL | 1064 nm<br>IDENTICAL | | | Laser Type | Flash lamp-excited,<br>pulsed dye laser<br>IDENTICAL | Flash lamp-<br>excited,<br>pulsed dye<br>laser<br>IDENTICAL | Flash lamp-excited, pulsed<br>dye laser<br>IDENTICAL | | | Flashlamp-excited,<br>Nd:YAG laser<br>(Vbeam Prima Only)<br>IDENTICAL | Flashlamp-excited,<br>Nd:YAG laser<br>IDENTICAL | | | Pulse Energy | Up to 12 J (Vbeam<br>Prima only)<br>IDENTICAL | Up to 12 J<br>IDENTICAL | Up to 8 J<br>IDENTICAL | | | Up to 8 J (Vbeam<br>Perfecta only)<br>IDENTICAL | Up to 45 J<br>IDENTICAL | | | | Up to 45 J (Vbeam<br>Prima only)<br>IDENTICAL | | | | Pulse Width | 0.45-40 ms<br>IDENTICAL | 0.45-40 ms<br>IDENTICAL | 0.45-40 ms<br>IDENTICAL | | | Up to 60 ms (Vbeam<br>Prima Only)<br>IDENTICAL | Up to 60 ms<br>IDENTICAL | | | Laser Pulse<br>Repetition<br>Rate | Up to 1.5 Hz<br>IDENTICAL | Up to 1.5<br>Hz<br>IDENTICAL | Up to 1.5 Hz<br>IDENTICAL | | | Up to 10 Hz ( Vbeam<br>Prima only)<br>IDENTICAL | Up to 10 Hz<br>IDENTICAL | | | General<br>Specifications | Candela Vbeam Family of Pulsed Dye<br>Lasers (Vbeam Prima, Vbeam Perfecta)<br>Proposed<br>Not Assigned | Vbeam Prima Laser System<br>Predicate<br>K183452 | Vbeam Perfecta<br>Predicate<br>K050673 | | Spot Size (mm) | DCD (Vbeam Prima only):<br>3-15mm HP<br>3x10mm HP<br>1.5 Zoom HP<br>CC (Vbeam Prima only):<br>3-15mm Zoom HP<br><br>Vbeam Perfecta Only:<br>3, 5, 7, 10, 12 millimeters and 3x10<br>(elliptical)<br>IDENTICAL | DCD:<br>3-15mm HP<br>3x10mm Zoom HP<br>1.5 ZHP<br>CC:<br>3-15mm Zoom HP<br>IDENTICAL | 3, 5, 7, 10, 12 millimeters<br>and 3x10 (elliptical)<br>IDENTICAL | | Electrical<br>Power | 200-240 VAC~; 4600 VA; 50/60 Hz ; single<br>phase (Vbeam Prima only)<br>IDENTICAL<br>20 - 230 V~ , 50/60 Hz, single phase, 4,000<br>VA or 17.4 A at 230 V~ (Vbeam Perfecta<br>only) | 200-240 VAC~; 4600 VA; 50/60<br>Hz ; single phase<br>IDENTICAL | 220 - 230 V~ , 50/60 Hz,<br>single phase, 4,000 VA or<br>17.4 A at 230 V~<br>IDENTICAL | | Physical<br>Dimensions<br>/Weight<br>(Console) | 280 lbs. (Vbeam Prima only)<br>IDENTICAL<br>290 lbs. (Vbeam Perfecta only)<br>IDENTICAL | 280 lbs.<br>IDENTICAL | 290 lbs.<br>IDENTICAL | | Patient<br>Contacting<br>Material | Distance Gauges: ULTEM 1000-1000<br>IDENTICAL | Distance Gauges: ULTEM 1000-<br>1000<br>IDENTICAL | Distance Gauges: ULTEM<br>1000-1000<br>IDENTICAL | # Table 1: Intended/Indication for use comparison table. {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ # Table 2: Technological & Biological specification comparison Page 9 of 16 {14}------------------------------------------------ {15}------------------------------------------------ # 9. PERFORMANCE DATA: # Performance Testing: Bench: The performance testing of the subject Candela Vbeam of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) is based on the established testing previous cleared under Vbeam Prima Laser System under its predicate K183452 and Vbeam Perfecta under its predicate K050673. There are no changes in the design therefore the subject Candela Vbeam of Pulsed Dye Lasers is based on the established performance testing of the device's predicates. # Performance Testing-Clinical A systematic literature search using PubMed, Embase and Cochrane databases, and a supplemental search in Clinicaltrials.gov, was conducted to identify peerreviewed articles in which the Vbeam PDL System with the 595-nm wavelength was used to treat cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas in the pediatric population. A total of 33 articles were identified that reported on randomized controlled, prospective, open label, evaluator-blinded clinical trials, or retrospective evaluator-blinded studies that treated at least 10 individuals in each study using the Vbeam 595-nm PDL. The studies were conducted globally in the USA, UK, Europe, and Asia, which included China, Japan, Taiwan, India, and the Middle East. Th…