(56 days)
Not Found
No
The document explicitly states "There is no new technology being introduced than what has been previously cleared". The focus is on expanding indications for existing laser technology.
Yes
The device is indicated for the treatment of various medical conditions such as benign cutaneous vascular lesions, rosacea, port wine stains, hemangiomas, warts, scars, psoriasis, acne vulgaris, and wrinkles, which constitutes therapeutic use.
No
The device is a treatment device (laser system) for various cutaneous conditions, not a diagnostic one. Its intended use includes photocoagulation and treatment of benign lesions and wrinkles.
No
The device description explicitly states it is a "Pulsed Dye Laser System" and refers to "Laser Systems," indicating it is a hardware device that utilizes software for its operation, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Vbeam Prima and Vbeam Perfecta are laser systems used for the treatment of various cutaneous vascular and benign lesions. They directly interact with the patient's body to perform photocoagulation and hemostasis.
- Intended Use: The intended uses listed are all related to therapeutic procedures performed directly on the patient's skin.
- Device Description: The description confirms it's a laser system used for treatment.
- Performance Studies: The performance studies focus on the clinical effectiveness of the laser in treating the specified conditions in patients, not on the accuracy of a diagnostic test.
Therefore, the Vbeam Prima and Vbeam Perfecta are therapeutic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
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.
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
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
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
pediatric population (neonates, infants, children, and adolescents), adult patients (up to 79 years)
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)
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. The 33 studies included a total of 7,725 patients of which 5,692 were pediatric (neonates, infants, children, and adolescents) Fitzpatrick Skin Type (FST) I-VI patients treated for hemanqioma (4.782 IH, 910 conqenital) and 1.354 were pediatric and 679 were pediatric and adult patients (up to 79 years) with Fitzpatrick Skin Type (FST) I- VI treated for PWS / cutaneous capillary malformation.
In conclusion, the data from these published reports support the intended indications for use of the Vbeam 595-nm PDL to treat cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemanqiomas (IH) / congenital hemangiomas in the pediatric population. The articles are identified in Table 3 below.
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 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:
510(k)
Product Code
Device Class | Candela Vbeam Family of
Pulsed Dye Lasers (Vbeam
Prima)
Proposed
Not Assigned
GEX
Class II | Vbeam Prima Laser System
Predicate
K183452
GEX
Class II | Vbeam Perfecta Laser System
Predicate
K050673
GEX
Class II |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use /
Indications: | Vbeam Prima is indicated for the
following:
595 nm:
General Surgery:
Ο Photocoagulation of
benign cutaneous
vascular lesions and
benign cutaneous
lesions.
Dermatology/Plastic Surgery:
Ο 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. | Vbeam Prima is indicated for
following:
595 nm:
General Surgery:
Ο Photocoagulation of
benign cutaneous
vascular lesions and
benign cutaneous
lesions.
Dermatology/Plastic Surgery:
Ο 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. | 595 nm:
General Surgery:
Ο Photocoagulation of benign
cutaneous vascular lesions
and benign cutaneous
lesions.
Dermatology/Plastic Surgery:
Ο 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.
Ο Treatment of Benign
Epidermal Pigmented
Lesions.
Ο Treatment of Inflammatory
Acne Vulgaris. |
| Name of Device:
510(k)
Product Code
Device Class | Candela Vbeam Family of
Pulsed Dye Lasers (Vbeam Prima)
Proposed
Not Assigned
GEX
Class II | Vbeam Prima Laser System
Predicate
K183452
GEX
Class II | Vbeam Perfecta Laser System
Predicate
K050673
GEX
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:
510(k)
Product Code
Device Class | Candela Vbeam Family of
Pulsed Dye Lasers (Vbeam
Prima)
Proposed
Not Assigned
GEX
Class II | Vbeam Prima Laser System
Predicate
K183452
GEX
Class II | Vbeam Perfecta Laser System
Predicate
K050673
GEX
Class II |
| | and hemostasis of benign
vascular lesions such as, but not to lentigos (age spots), solar
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. | 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 is indicated for
the following:
595 nm:
General Surgery:
• Photocoagulation of
benign cutaneous
vascular lesions and
benign cutaneous | | |
| Name of Device:
510(k)
Product Code
Device Class | Candela Vbeam Family of
Pulsed Dye Lasers (Vbeam
Prima)
Proposed
Not Assigned
GEX
Class II | Vbeam Prima Laser System
Predicate
K183452
GEX
Class II | Vbeam Perfecta Laser System
Predicate
K050673
GEX
Class II |
| | 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. | | |
| Name of Device:
510(k)
Product Code
Device Class | Candela Vbeam Family of
Pulsed Dye Lasers (Vbeam
Prima)
Proposed
Not Assigned
GEX
Class II | Vbeam Prima Laser System
Predicate
K183452
GEX
Class II | Vbeam Perfecta Laser System
Predicate
K050673
GEX
Class II |
| | 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 | | |
| Similarities/Differences | Identical to Predicate device, but
with expanded indications
identified in BOLD . | Identical to the subject device,
but without the expanded
indications. | Identical to the subject device, but
without the expanded indications. |
| General
Specifications | Candela Vbeam Family of Pulsed Dye
Lasers (Vbeam Prima, Vbeam Perfecta)
Proposed
Not Assigned | Vbeam Prima Laser System
Predicate
K183452 | Vbeam Perfecta
Predicate
K050673 |
| Technical
Characteristics | Identical | Identical | Identical |
| Wavelength | 595 nm
IDENTICAL | 595 nm
IDENTICAL | 595 nm
IDENTICAL |
| | 1064 nm (Vbeam
Prima only)
IDENTICAL | 1064 nm
IDENTICAL | |
| Laser Type | Flash lamp-excited,
pulsed dye laser
IDENTICAL | Flash lamp-
excited,
pulsed dye
laser
IDENTICAL | Flash lamp-excited, pulsed
dye laser
IDENTICAL |
| | Flashlamp-excited,
Nd:YAG laser
(Vbeam Prima Only)
IDENTICAL | Flashlamp-excited,
Nd:YAG laser
IDENTICAL | |
| Pulse Energy | Up to 12 J (Vbeam
Prima only)
IDENTICAL | Up to 12 J
IDENTICAL | Up to 8 J
IDENTICAL |
| | Up to 8 J (Vbeam
Perfecta only)
IDENTICAL | Up to 45 J
IDENTICAL | |
| | Up to 45 J (Vbeam
Prima only)
IDENTICAL | | |
| Pulse Width | 0.45-40 ms
IDENTICAL | 0.45-40 ms
IDENTICAL | 0.45-40 ms
IDENTICAL |
| | Up to 60 ms (Vbeam
Prima Only)
IDENTICAL | Up to 60 ms
IDENTICAL | |
| Laser Pulse
Repetition
Rate | Up to 1.5 Hz
IDENTICAL | Up to 1.5
Hz
IDENTICAL | Up to 1.5 Hz
IDENTICAL |
| | Up to 10 Hz ( Vbeam
Prima only)
IDENTICAL | Up to 10 Hz
IDENTICAL | |
| General
Specifications | Candela Vbeam Family of Pulsed Dye
Lasers (Vbeam Prima, Vbeam Perfecta)
Proposed
Not Assigned | Vbeam Prima Laser System
Predicate
K183452 | Vbeam Perfecta
Predicate
K050673 |
| Spot Size (mm) | DCD (Vbeam Prima only):
3-15mm HP
3x10mm HP
1.5 Zoom HP
CC (Vbeam Prima only):
3-15mm Zoom HP
Vbeam Perfecta Only:
3, 5, 7, 10, 12 millimeters and 3x10
(elliptical)
IDENTICAL | DCD:
3-15mm HP
3x10mm Zoom HP
1.5 ZHP
CC:
3-15mm Zoom HP
IDENTICAL | 3, 5, 7, 10, 12 millimeters
and 3x10 (elliptical)
IDENTICAL |
| Electrical
Power | 200-240 VAC~; 4600 VA; 50/60 Hz ; single
phase (Vbeam Prima only)
IDENTICAL
20 - 230 V~ , 50/60 Hz, single phase, 4,000
VA or 17.4 A at 230 V~ (Vbeam Perfecta
only) | 200-240 VAC~; 4600 VA; 50/60
Hz ; single phase
IDENTICAL | 220 - 230 V~ , 50/60 Hz,
single phase, 4,000 VA or
17.4 A at 230 V~
IDENTICAL |
| Physical
Dimensions
/Weight
(Console) | 280 lbs. (Vbeam Prima only)
IDENTICAL
290 lbs. (Vbeam Perfecta only)
IDENTICAL | 280 lbs.
IDENTICAL | 290 lbs.
IDENTICAL |
| Patient
Contacting
Material | Distance Gauges: ULTEM 1000-1000
IDENTICAL | Distance Gauges: ULTEM 1000-
1000
IDENTICAL | Distance Gauges: ULTEM
1000-1000
IDENTICAL |
Table 1: Intended/Indication for use comparison table.
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Table 2: Technological & Biological specification comparison
Page 9 of 16
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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. The 33 studies included a total of 7,725 patients of which 5,692 were pediatric (neonates, infants, children, and adolescents) Fitzpatrick Skin Type (FST) I-VI patients treated for hemanqioma (4.782 IH, 910 conqenital) and 1.354 were pediatric and 679 were pediatric and adult patients (up to 79 years) with Fitzpatrick Skin Type (FST) I- VI treated for PWS / cutaneous capillary malformation.
In conclusion, the data from these published reports support the intended indications for use of the Vbeam 595-nm PDL to treat cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemanqiomas (IH) / congenital hemangiomas in the pediatric population. The articles are identified in Table 3 below.
| No. | Citation | Indication(s): |
|---|---|---|
| 1 | Zhang W, Li F, Yang Y, Xue L, Cao M, Wang L. | |
| Hemangioma treatment with pulsed dye laser- | ||
| distinct parameters used between | ||
| neonatal and non-neonatal patients. J | ||
| Cosmet Laser Ther. 2016 Nov;18(7):389- |
- doi: 10.1080/14764172.2016.1197402. | Infantile Hemangiomas
(pediatric) |
| 2 | Yang B, Li L, Zhang LX, Sun YJ, Ma L. Clinical
Characteristics and Treatment Options of Infantile
Vascular Anomalies. Medicine (Baltimore). 2015
Oct;94(40):e1717. doi: | Vascular Anomalies in
children including Infantile
Hemangioma &
Port Wine Stain |
| No. | Citation | Indication(s): |
| | 10.1097/MD.0000000000001717. | |
| 3 | Sadeghinia A, Moghaddas S, Tavakolpour S, Teimourpour A, Danespazhooh M, Mahmoudi H. Treatment of port wine stains with 595-nm pulsed dye laser in 27 pediatric patients: A prospective study in the Iranian population. J Cosmet Laser Ther. 2019;21(7-8):373-377. doi: 10.1080/14764172.2019.1661489. | Port Wine Stain (pediatric) |
| 4 | Yu W, Cen Q, Chen Y, Zhu J, Lin X. Combination Therapy of Pulsed Dye Laser With Intense Pulsed Light in Port-Wine Stain Treatment: A Prospective Side-by-Side Comparison. Dermatol Surg. 2021 Sep 1;47(9):1229-1232. doi: 10.1097/DSS.0000000000003114. | Port Wine Stain (pediatric and adult) |
| 5 | Fallahi M, Hallaji Z, Tavakolpour S, Niknam S, Salehi Farid A, Nili A, Teimourpour A, Daneshpazhooh M, Rahmati J, Haddady Abianeh S, Mahmoudi H. Evaluating the efficacy and safety of topical sirolimus 0.2% cream as adjuvant therapy with pulsed dye laser for the treatment of port wine stain: A randomized, double-blind, placebo-controlled trial. J Cosmet Dermatol. 2021 Aug;20(8):2498-2506. doi: 10.1111/jocd.13867. | Port Wine Stain (pediatric and adult) |
| 6 | Yu W, Ma G, Qiu Y, Chen H, Jin Y, Yang X, Chang L, Wang T, Hu X, Li W, Lin X. Prospective comparison treatment of 595-nm pulsed-dye lasers for virgin port-wine stain. Br J Dermatol. 2015 Mar;172(3):684-91. doi: 10.1111/bjd.13356. | Port Wine Stain (pediatric) |
| 7 | Bernstein EF. High-energy 595 nm pulsed dye laser improves refractory port-wine stains. Dermatol Surg. 2006 Jan;32(1):26-33. doi: 10.1111/1524-4725.2006.32003. | Port Wine Stain (pediatric and adult) |
| 8 | Yu W, Wang T, Zhu J, Qiu Y, Chen H, Jin Y, Yang X, Hu X, Chang L, Chen Y, Ma G, Lin X. EMLA cream does not influence efficacy and pain reduction during pulsed-dye laser treatment of port-wine stain: a prospective side-by-side comparison. Lasers Med Sci. 2018 Apr;33(3):573-579. doi: 10.1007/s10103-017-2415-3. | Port Wine Stain (pediatric and adult) |
| 9 | Yu W, Zhu J, Changc SJ, Chen H, Jin Y, Yang X, Wang T, Chang L, Chen Y, Ma G, Lin X. Shorter Treatment Intervals of East Asians with Port-Wine Stain with Pulsed Dye Laser Are Safe and Effective-A Prospective Side-by-Side Comparison. Photomed Laser Surg. 2018 Jan;36(1):37-43. doi: 10.1089/pho.2017.4315. | Port Wine Stain (pediatric and adult) |
| No. | Citation | Indication(s): |
| 10 | Zhu J, Yu W, Wang T, Chen Y, Lyu D, Chang L, Ma G, Lin X. Less is more: similar efficacy in three sessions and seven sessions of pulsed dye laser treatment in infantile port-wine stain patients. Lasers Med Sci.
2018 Nov;33(8):1707-1715. doi: 10.1007/s10103-018-2525-6. | Port Wine Stain (pediatric) |
| 11 | Brauer JA, Farhadian JA, Bernstein LJ, Bae YS, Geronemus RG. Pulsed Dye Laser at Subpurpuric Settings for the Treatment of Pulsed Dye Laser-Induced Ecchymoses in Patients With Port-Wine Stains. Dermatol Surg. 2018 Feb;44(2):220-226. doi: 10.1097/DSS.0000000000001255. | Port Wine Stain (pediatric and adult) |
| 12 | Yu W, Zhu J, Wang L, Qiu Y, Chen Y, Yang X, Chang L, Ma G, Lin X. Double Pass 595 nm Pulsed Dye Laser Does Not Enhance the Efficacy of Port Wine Stains Compared with Single Pass: A Randomized
Comparison with Histological Examination. Photomed Laser Surg. 2018 Jun;36(6):305-312. doi: 10.1089/pho.2017.4392. | Virgin Port Wine Stain (pediatric and adult) |
| 13 | Yu W, Ying H, Chen Y, Qiu Y, Chen H, Jin Y, Yang X, Wang T, Ma G, Lin X. In Vivo Investigation of the Safety and Efficacy of Pulsed Dye Laser with Two Spot Sizes in Port-Wine Stain Treatment: A Prospective
Side-by-Side Comparison. Photomed Laser Surg. 2017 Sep;35(9):465-471. doi: 10.1089/pho.2016.4186. | Port Wine Stain (pediatric and adult) |
| 14 | Faurschou A, Togsverd-Bo K, Zachariae C, Haedersdal M. Pulsed dye laser vs. intense pulsed light for port-wine stains: a randomized side-by- side trial with blinded response evaluation. Br J Dermatol. 2009
Feb;160(2):359-64. doi: 10.1111/j.1365-2133.2008.08993.x. | Port Wine Stain (pediatric and adult) |
| 15 | Yung A, Sheehan-Dare R. A comparative study of a 595-nm with a 585-nm pulsed dye laser in refractory port wine stains. Br J Dermatol. 2005 Sep;153(3):601-6. doi: 10.1111/j.1365-2133.2005.06707.x. | Refractory Port Wine Stain (pediatric and adult) |
| 16 | Yu W, Ma G, Qiu Y, Chen H, Jin Y, Yang X, Hu X, Wang T, Chang L, Zhou H, Li W, Lin X. Why do port-wine stains (PWS) on the lateral face respond better to pulsed dye laser (PDL) than those located on the central face? J Am Acad Dermatol. 2016
Mar;74(3):527-35. doi: 10.1016/j.jaad.2015.08.026. | Port Wine Stain (pediatric and adult) |
| 17 | Li L, Kono T, Groff WF, Chan HH, Kitazawa Y, Nozaki M. Comparison study of a long-pulse pulsed dye laser and a long-pulse pulsed alexandrite laser in the treatment of port | Port Wine Stain (pediatric and adult) |
| No. | Citation | Indication(s): |
| | wine stains. J Cosmet Laser Ther. 2008
Mar;10(1):12-5. doi: 10.1080/14764170701817023. | |
| 18 | Tomson N, Lim SP, Abdullah A, Lanigan SW. The
treatment of port- wine stains with the pulsed-dye
laser at 2-week and 6-week intervals: a
comparative study. Br J Dermatol. 2006
Apr;154(4):676-9. doi: 10.1111/j.1365-
2133.2005.07113.x. | Port Wine Stain (pediatric and
adult) |
| 19 | Asahina A, Watanabe T, Kishi A, Hattori N, Shirai
A, Kagami S, Watanabe R, Le Pavoux A,
Maekawa T, Tamaki K, Ohara K. Evaluation of the
treatment of port-wine stains with the 595-nm long
pulsed dye laser: a large prospective study in adult
Japanese patients. J Am Acad Dermatol. 2006
Mar;54(3):487-93. doi:
10.1016/j.jaad.2005.11.1034. | Port Wine Stain (pediatric and
adult) |
| 20 | Liu S, Yang C, Yang S, Wang Z, Luo D, Zhang X.
Topical application of 5-aminolevulinic acid
followed by 595-nm pulsed dye laser irradiation for
the treatment of recalcitrant port-wine stains: a
primary study. J Cosmet Laser Ther. 2012
Aug;14(4):189-92. doi:
10.3109/14764172.2012.699677. | Recalcitrant Port Wine Stain
(pediatric and adult) |
| 21 | Woo WK, Jasim ZF, Handley JM. Evaluating the
efficacy of treatment of resistant port-wine stains
with variable-pulse 595-nm pulsed dye and
532-nm Nd:YAG lasers. Dermatol Surg. 2004
Feb;30(2 Pt 1):158-62; discussion 162. doi:
10.1046/j.1076-0512.2003.30055.x. | Port Wine Stain (pediatric and
adult) |
| 22 | Peters MA, van Drooge AM, Wolkerstorfer A, van
Gemert MJ, van der Veen JP, Bos JD, Beek JF.
Double pass 595 nm pulsed dye laser at a 6
minute interval for the treatment of port-wine stains
is not more effective than single pass. Lasers Surg
Med. 2012 Mar;44(3):199-204.
doi: 10.1002/lsm.22011. | Port Wine Stain (pediatric and
adult) |
| 23 | Tremaine AM, Armstrong J, Huang YC, Elkeeb L,
Ortiz A, Harris R, Choi B, Kelly KM. Enhanced port-
wine stain lightening achieved with combined
treatment of selective photothermolysis and
imiquimod. J Am Acad Dermatol. 2012
Apr;66(4):634-41. doi:
10.1016/j.jaad.2011.11.958. | Port Wine Stain (pediatric and
adult) |
| 24 | Frohm Nilsson M, Passian S, Wiegleb Edstrom D.
Comparison of two dye lasers in the treatment of
port-wine stains. Clin Exp Dermatol. 2010
Mar;35(2):126-30. doi: 10.1111/j.1365- | Port Wine Stain (pediatric and
adult) |
| No. | Citation | Indication(s): |
| | 2230.2009.03399.x. | |
| 25 | Thajudheen CP, Jyothy K, Priyadarshini A. Treatment of port-wine stains with flash lamp pumped pulsed dye laser on Indian skin: a six year study. J Cutan Aesthet Surg. 2014 Jan;7(1):32-6. doi: 10.4103/0974-2077.129973. | Port Wine Stain (pediatric and adult) |
| 26 | He HY, Shi WK, Jiang JC, Gao Y, Xue XM. An exploration of optimal time and safety of 595-nm pulsed dye laser for the treatment of early superficial infantile hemangioma. Dermatol Ther. 2022 May;35(5):e15406. doi: 10.1111/dth.15406. | Infantile Hemangioma (pediatric) |
| 27 | Kono T, Sakurai H, Groff WF, Chan HH, Takeuchi M, Yamaki T, Soejima K, Nozaki M. Comparison study of a traditional pulsed dye laser versus a long-pulsed dye laser in the treatment of early childhood hemangiomas. Lasers Surg Med. 2006 Feb;38(2):112-5. doi: 10.1002/lsm.20257. | Hemangioma (pediatric) |
| 28 | Hartmann F, Lockmann A, Grönemeyer LL, Haenssle HA, Zutt M, von Fintel H, Kühnle I, Schön MP, Thoms KM. Nd:YAG and pulsed dye laser therapy in infantile haemangiomas: a retrospective analysis of 271 treated haemangiomas in 149 children. J Eur Acad Dermatol Venereol. 2017 Aug;31(8):1372-1379. doi: 10.1111/jdv.14074. | Infantile Hemangioma (pediatric) |
| 29 | Lin MY, Lin CS, Hu S, Chang JM, Chung WH, Zhang ZY, Chang SC, Huo YP. The application of 595-nm pulsed dye laser for vascular anomalies in a Chinese population: a 10-year experience. J Cosmet Laser Ther. 2019;21(3):171-178. doi: 10.1080/14764172.2018.1502450. | Vascular Anomalies including Infantile Hemangioma (pediatric) & Port Wine Stain (pediatric and adult) |
| 30 | Rinaldi G, Creissen A, Mahon C, Syed SB. Triple pass laser therapy for recalcitrant facial port wine stains. Lasers Med Sci. 2022 Apr;37(3):1643-1650. doi: 10.1007/s10103-021-03414-x. | Port Wine Stain (pediatric) |
| 31 | Li D, Chen B, Zhang H, Yuan Y, Fan W, Ying Z. Retrospective study of the treatment of port-wine stains with 595-nm pulsed dye laser in 261 Chinese patients. Lasers Med Sci. 2020 Oct;35(8):1811-1819. doi: 10.1007/s10103-020-03013-2. | Port Wine Stain (pediatric and adult) |
| 32 | Jeon H, Bernstein LJ, Belkin DA, Ghalili S, Geronemus RG. Pulsed Dye Laser Treatment of Port-Wine Stains in Infancy Without the Need for General Anesthesia. JAMA Dermatol. 2019 Apr | Port Wine Stain (pediatric) |
| No. | Citation | Indication(s): |
| | 1;155(4):435-441.
doi: 10.1001/jamadermatol.2018.5249. | |
| 33 | Hartmann F, Lockmann A, Himpel O, Kühnle I,
Hensen J, Schön MP, Thoms KM. Combination
therapy of oral propranolol and combined
Nd:YAG/pulsed dye laser therapy in infantile
hemangiomas: a retrospective analysis of 48 treated
hemangiomas in 30 children. J Dtsch
Dermatol Ges. 2020 Sep;18(9):984-993. doi:
10.1111/ddg.14184. | Infantile Hemangioma
(pediatric) |
Table 3. Identification of Clinical Articles in Candela Vbeam Pulse Dyed Lasers literature search analysis
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10. Substantial Equivalence Comparison
When comparing the subject Candela Vbeam of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) is identical to the previously cleared Vbeam Prima Laser System under K183452 and Vbeam Perfecta under K050673. The additional indications for use do not raise any new issues of safety and effectiveness. There are no technological changes between the subject and predicate devices. The subject Candela Vbeam of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) is substantially equivalent, in terms of technological characteristics, performance, and intended use to the predicate devices Vbeam Prima Laser System under K183452 and Vbeam Perfecta under K050673 as they are identical.