(56 days)
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
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.
The provided text from the FDA 510(k) summary (K230990 for Candela Vbeam Family of Pulsed Dye Lasers) does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. Instead, it details the substantial equivalence determination for an expanded indication (treatment of cutaneous capillary malformations and infantile/congenital hemangiomas in the pediatric population) for devices (Vbeam Prima and Vbeam Perfecta) that were previously cleared.
The 510(k) summary states that:
- There are no new technologies being introduced.
- The device is identical in design, function, and intended use to its previously cleared Vbeam Prima Laser System (K183452) and Vbeam Perfecta (K050673) predicates.
- The expanded indications do not raise any new concerns of safety or effectiveness.
Therefore, the performance data provided relies on:
-
Bench testing: "based on the established testing previously 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." This implies that prior acceptance criteria for the predicate devices are considered met for the new device due to identical design. No specific quantitative acceptance criteria or results from this bench testing are provided in the document.
-
Clinical Performance: A systematic literature search was conducted to support the expanded pediatric indications. This is not a direct study proving the device meets an acceptance criterion "for the device itself," but rather a review of existing clinical evidence to support the safety and effectiveness of the treatment method (Vbeam 595-nm PDL) for the expanded indications.
Given this, I cannot fill in a table of acceptance criteria and reported device performance directly from this document, as the document explicitly states there are no changes to the device itself and it relies on the predicate's established performance. The "performance data" presented for the new indication is effectively a literature review.
However, I can extract information related to the clinical literature review used to support the new indication:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for Device (Implied): The device (Vbeam Prima and Vbeam Perfecta) must perform identically to its predicate devices, as no design changes were made. The performance is assessed on the safety and effectiveness of the 595-nm PDL for the target conditions based on existing literature. No specific quantitative performance metrics (e.g., laser fluence accuracy, pulse stability) are provided in this summary for the "acceptance criteria" of the device itself for this 510(k) submission, as it relies on the prior clearance of the predicate.
- Reported Device Performance (from literature review): The studies reviewed "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 hemangiomas (IH) / congenital hemangiomas in the pediatric population." Details on specific outcome measures (e.g., percentage improvement in lesion appearance, adverse event rates) from these studies are not summarized or quantified in this 510(k) document, only that the literature generally supports the use.
2. Sample size used for the test set and the data provenance:
- Test Set (Literature Review): A total of 33 articles were identified.
- Total Patients: 7,725
- Pediatric Patients (Hemangioma): 5,692 (4,782 IH, 910 congenital)
- Pediatric & Adult Patients (PWS/Capillary Malformation): 1,354 pediatric and 679 pediatric and adult.
- Data Provenance: The studies were conducted globally, specifically listed as from the USA, UK, Europe, and Asia (including China, Japan, Taiwan, India, and the Middle East). The studies included randomized controlled, prospective, open label, evaluator-blinded clinical trials, or retrospective evaluator-blinded studies. The data is retrospective in the sense that it relies on previously published research.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the 510(k) summary. The ground truth for the efficacy and safety of the treatment would have been established by the methods within each of the 33 individual published studies (e.g., clinical assessment by dermatologists, photographic evaluation, patient-reported outcomes). The 510(k) summary only reviews the conclusions of these studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided as it's a literature review, not a de novo clinical study with a central adjudication panel. Adjudication methods would vary by individual study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was performed or referenced in this document. This submission is for a laser device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a laser device for treatment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the effectiveness of the treatment, as drawn from the literature review, is based on clinical outcomes data reported in peer-reviewed articles. This would typically include assessments of lesion clearance/improvement, photographic documentation, and safety outcomes (adverse events). Specific types of ground truth would vary by individual study design (e.g., some studies might use standardized scales for improvement, others might rely on subjective expert assessment).
8. The sample size for the training set:
- Not applicable. This is a laser device, not a machine learning algorithm requiring a "training set." The clinical literature review serves as the evidentiary basis for the expanded indication.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for a machine learning model is involved.
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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
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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
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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.
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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."
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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."
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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
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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
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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.
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| Name of Device:510(k)Product CodeDevice Class | Candela Vbeam Family ofPulsed Dye Lasers (VbeamPrima)ProposedNot AssignedGEXClass II | Vbeam Prima Laser SystemPredicateK183452GEXClass II | Vbeam Perfecta Laser SystemPredicateK050673GEXClass II |
|---|---|---|---|
| Intended use /Indications: | Vbeam Prima is indicated for thefollowing:595 nm:General Surgery:Ο Photocoagulation ofbenign cutaneousvascular lesions andbenign cutaneouslesions.Dermatology/Plastic Surgery:Ο For treatment of benigncutaneous vascularlesions, such as facialand leg telangiectasia,rosacea, port winestains, hemangiomas,angioma, spiderangioma, Poikiloderma ofCivatte, and benigncutaneous lesions, suchas warts, scars, striaeand Psoriasis and thetreatment of wrinkles. | Vbeam Prima is indicated forfollowing:595 nm:General Surgery:Ο Photocoagulation ofbenign cutaneousvascular lesions andbenign cutaneouslesions.Dermatology/Plastic Surgery:Ο For treatment of benigncutaneous vascularlesions, such as facialand leg telangiectasia,rosacea, port winestains, hemangiomas,angioma, spiderangioma, Poikilodermaof Civatte, and benigncutaneous lesions, suchas warts, scars, striaeand Psoriasis and thetreatment of wrinkles. | 595 nm:General Surgery:Ο Photocoagulation of benigncutaneous vascular lesionsand benign cutaneouslesions.Dermatology/Plastic Surgery:Ο For treatment of benigncutaneous vascular lesions,such as facial and legtelangiectasia, rosacea, portwine stains, hemangiomas,angioma, spider angioma,Poikiloderma of Civatte, andbenign cutaneous lesions,such as warts, scars, striaeand Psoriasis and thetreatment of wrinkles.Ο Treatment of BenignEpidermal PigmentedLesions.Ο Treatment of InflammatoryAcne Vulgaris. |
| Name of Device:510(k)Product CodeDevice Class | Candela Vbeam Family ofPulsed Dye Lasers (Vbeam Prima)ProposedNot AssignedGEXClass II | Vbeam Prima Laser SystemPredicateK183452GEXClass II | Vbeam Perfecta Laser SystemPredicateK050673GEXClass 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 CodeDevice Class | Candela Vbeam Family ofPulsed Dye Lasers (VbeamPrima)ProposedNot AssignedGEXClass II | Vbeam Prima Laser SystemPredicateK183452GEXClass II | Vbeam Perfecta Laser SystemPredicateK050673GEXClass II |
| and hemostasis of benignvascular lesions such as, but not to lentigos (age spots), solarlimited to, port wine stains,hemangiomas, warts,telangiectasia, rosacea, Venuslakes, leg veins, spider veins,and poikiloderma of Civatte andtreatment of benign cutaneouslesions such as, but not limitedto lentigos (age spots), solarlentigos (sun spots), café-au-laitmacules, seborrheic keratoses,nevi, chloasma, verrucae, skintags, and keratoses. The laser isalso indicated for the treatmentof wrinkles such as, but notlimited to, peri-ocular and peri-oral wrinkles. | lesions such as, but not limitedto lentigos (age spots), solarlentigos (sun spots), café-au-laitmacules, seborrheic keratoses,nevi, chloasma, verrucae, skintags, and keratoses. The laseris also indicated for thetreatment of wrinkles such as,but not limited to, peri-ocularand peri-oral wrinkles. | ||
| Vbeam Perfecta is indicated forthe following:595 nm:General Surgery:• Photocoagulation ofbenign cutaneousvascular lesions andbenign cutaneous | |||
| Name of Device:510(k)Product CodeDevice Class | Candela Vbeam Family ofPulsed Dye Lasers (VbeamPrima)ProposedNot AssignedGEXClass II | Vbeam Prima Laser SystemPredicateK183452GEXClass II | Vbeam Perfecta Laser SystemPredicateK050673GEXClass II |
| lesions.Dermatology/Plastic Surgery:• For treatment of benigncutaneous vascularlesions, such as facialand leg telangiectasia,rosacea, port winestains, hemangiomas,angioma, spiderangioma, Poikiloderma ofCivatte, and benigncutaneous lesions, suchas warts, scars, striaeand Psoriasis and thetreatment of wrinkles.• Treatment of BenignEpidermal PigmentedLesions.• Treatment ofInflammatory AcneVulgaris.Gynecology:• Photocoagulation ofbenign cutaneous lesionsand benign vascularlesions in gynecology. | |||
| Name of Device:510(k)Product CodeDevice Class | Candela Vbeam Family ofPulsed Dye Lasers (VbeamPrima)ProposedNot AssignedGEXClass II | Vbeam Prima Laser SystemPredicateK183452GEXClass II | Vbeam Perfecta Laser SystemPredicateK050673GEXClass II |
| Podiatry:• Treatment of benigncutaneous lesions, suchas warts.Pediatric Population:Treatment of cutaneouscapillary malformations, alsoknown as port wine stains(PWS), and infantilehemangiomas (IH) / congenitalhemangiomas | |||
| Similarities/Differences | Identical to Predicate device, butwith expanded indicationsidentified in BOLD . | Identical to the subject device,but without the expandedindications. | Identical to the subject device, butwithout the expanded indications. |
| GeneralSpecifications | Candela Vbeam Family of Pulsed DyeLasers (Vbeam Prima, Vbeam Perfecta)ProposedNot Assigned | Vbeam Prima Laser SystemPredicateK183452 | Vbeam PerfectaPredicateK050673 |
| TechnicalCharacteristics | Identical | Identical | Identical |
| Wavelength | 595 nmIDENTICAL | 595 nmIDENTICAL | 595 nmIDENTICAL |
| 1064 nm (VbeamPrima only)IDENTICAL | 1064 nmIDENTICAL | ||
| Laser Type | Flash lamp-excited,pulsed dye laserIDENTICAL | Flash lamp-excited,pulsed dyelaserIDENTICAL | Flash lamp-excited, pulseddye laserIDENTICAL |
| Flashlamp-excited,Nd:YAG laser(Vbeam Prima Only)IDENTICAL | Flashlamp-excited,Nd:YAG laserIDENTICAL | ||
| Pulse Energy | Up to 12 J (VbeamPrima only)IDENTICAL | Up to 12 JIDENTICAL | Up to 8 JIDENTICAL |
| Up to 8 J (VbeamPerfecta only)IDENTICAL | Up to 45 JIDENTICAL | ||
| Up to 45 J (VbeamPrima only)IDENTICAL | |||
| Pulse Width | 0.45-40 msIDENTICAL | 0.45-40 msIDENTICAL | 0.45-40 msIDENTICAL |
| Up to 60 ms (VbeamPrima Only)IDENTICAL | Up to 60 msIDENTICAL | ||
| Laser PulseRepetitionRate | Up to 1.5 HzIDENTICAL | Up to 1.5HzIDENTICAL | Up to 1.5 HzIDENTICAL |
| Up to 10 Hz ( VbeamPrima only)IDENTICAL | Up to 10 HzIDENTICAL | ||
| GeneralSpecifications | Candela Vbeam Family of Pulsed DyeLasers (Vbeam Prima, Vbeam Perfecta)ProposedNot Assigned | Vbeam Prima Laser SystemPredicateK183452 | Vbeam PerfectaPredicateK050673 |
| Spot Size (mm) | DCD (Vbeam Prima only):3-15mm HP3x10mm HP1.5 Zoom HPCC (Vbeam Prima only):3-15mm Zoom HPVbeam Perfecta Only:3, 5, 7, 10, 12 millimeters and 3x10(elliptical)IDENTICAL | DCD:3-15mm HP3x10mm Zoom HP1.5 ZHPCC:3-15mm Zoom HPIDENTICAL | 3, 5, 7, 10, 12 millimetersand 3x10 (elliptical)IDENTICAL |
| ElectricalPower | 200-240 VAC~; 4600 VA; 50/60 Hz ; singlephase (Vbeam Prima only)IDENTICAL20 - 230 V~ , 50/60 Hz, single phase, 4,000VA or 17.4 A at 230 V~ (Vbeam Perfectaonly) | 200-240 VAC~; 4600 VA; 50/60Hz ; single phaseIDENTICAL | 220 - 230 V~ , 50/60 Hz,single phase, 4,000 VA or17.4 A at 230 V~IDENTICAL |
| PhysicalDimensions/Weight(Console) | 280 lbs. (Vbeam Prima only)IDENTICAL290 lbs. (Vbeam Perfecta only)IDENTICAL | 280 lbs.IDENTICAL | 290 lbs.IDENTICAL |
| PatientContactingMaterial | Distance Gauges: ULTEM 1000-1000IDENTICAL | Distance Gauges: ULTEM 1000-1000IDENTICAL | Distance Gauges: ULTEM1000-1000IDENTICAL |
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 betweenneonatal and non-neonatal patients. JCosmet Laser Ther. 2016 Nov;18(7):389-392. doi: 10.1080/14764172.2016.1197402. | Infantile Hemangiomas(pediatric) |
| 2 | Yang B, Li L, Zhang LX, Sun YJ, Ma L. ClinicalCharacteristics and Treatment Options of InfantileVascular Anomalies. Medicine (Baltimore). 2015Oct;94(40):e1717. doi: | Vascular Anomalies inchildren including InfantileHemangioma &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 RandomizedComparison 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 ProspectiveSide-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. 2009Feb;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. 2016Mar;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. 2008Mar;10(1):12-5. doi: 10.1080/14764170701817023. | ||
| 18 | Tomson N, Lim SP, Abdullah A, Lanigan SW. Thetreatment of port- wine stains with the pulsed-dyelaser at 2-week and 6-week intervals: acomparative study. Br J Dermatol. 2006Apr;154(4):676-9. doi: 10.1111/j.1365-2133.2005.07113.x. | Port Wine Stain (pediatric andadult) |
| 19 | Asahina A, Watanabe T, Kishi A, Hattori N, ShiraiA, Kagami S, Watanabe R, Le Pavoux A,Maekawa T, Tamaki K, Ohara K. Evaluation of thetreatment of port-wine stains with the 595-nm longpulsed dye laser: a large prospective study in adultJapanese patients. J Am Acad Dermatol. 2006Mar;54(3):487-93. doi:10.1016/j.jaad.2005.11.1034. | Port Wine Stain (pediatric andadult) |
| 20 | Liu S, Yang C, Yang S, Wang Z, Luo D, Zhang X.Topical application of 5-aminolevulinic acidfollowed by 595-nm pulsed dye laser irradiation forthe treatment of recalcitrant port-wine stains: aprimary study. J Cosmet Laser Ther. 2012Aug;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 theefficacy of treatment of resistant port-wine stainswith variable-pulse 595-nm pulsed dye and532-nm Nd:YAG lasers. Dermatol Surg. 2004Feb;30(2 Pt 1):158-62; discussion 162. doi:10.1046/j.1076-0512.2003.30055.x. | Port Wine Stain (pediatric andadult) |
| 22 | Peters MA, van Drooge AM, Wolkerstorfer A, vanGemert MJ, van der Veen JP, Bos JD, Beek JF.Double pass 595 nm pulsed dye laser at a 6minute interval for the treatment of port-wine stainsis not more effective than single pass. Lasers SurgMed. 2012 Mar;44(3):199-204.doi: 10.1002/lsm.22011. | Port Wine Stain (pediatric andadult) |
| 23 | Tremaine AM, Armstrong J, Huang YC, Elkeeb L,Ortiz A, Harris R, Choi B, Kelly KM. Enhanced port-wine stain lightening achieved with combinedtreatment of selective photothermolysis andimiquimod. J Am Acad Dermatol. 2012Apr;66(4):634-41. doi:10.1016/j.jaad.2011.11.958. | Port Wine Stain (pediatric andadult) |
| 24 | Frohm Nilsson M, Passian S, Wiegleb Edstrom D.Comparison of two dye lasers in the treatment ofport-wine stains. Clin Exp Dermatol. 2010Mar;35(2):126-30. doi: 10.1111/j.1365- | Port Wine Stain (pediatric andadult) |
| 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. Combinationtherapy of oral propranolol and combinedNd:YAG/pulsed dye laser therapy in infantilehemangiomas: a retrospective analysis of 48 treatedhemangiomas in 30 children. J DtschDermatol 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.
§ 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.