(204 days)
The PicoWay laser system is indicated for the following at the specified wavelength:
- · 532 mm: Removal of tattoos for Fitzpatrick Skin Types I-III to treat the following tattoo colors: red, yellow and orange.
- · 730 nm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue.
- · 785 mm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue.
· 1064 nm: Removal of tattoos for all Fitzpatrick Skin Types to treat the following tattoo colors: black, brown, green, blue and purple.
The Pico Way laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V and for treatment of Melasma for Fitzpatrick Skin Types I-IV.
The Resolve handpieces (532 nm, and 1064 nm) are also indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV.
The Resolve Fusion handpiece (532 nm) is indicated for benign pigmented for Fitzpatrick Skin Types I-IV.
The PicoWay laser system is indicated for the following at the specified wavelengths:
532 nm :
· Treatment of Melasma for Fitzpatrick Skin Types I-IV.
· Treatment of café au lait macules (CALMs) for Fitzpatrick Skin Types I-IV.
- · Treatment of Lentigines for Fitzpatrick Skin Types I-IV.
730 nm:
· Treatment of Lentigines for Fitzpatrick Skin Types I-IV.
1064 nm:
- · Treatment of Melasma for Fitzpatrick Skin Types I-IV.
- · Treatment of Nevus of Ota for Fitzpatrick Skin Types III-IV.
The PicoWay Laser System is a solid-state laser capable of delivering energy at wavelengths of 1064 nm, 532 nm, or 730 nm, at extremely short duration in the range of 240-500 (ps). The laser system contains one 755 nm (Alexandrite) laser head which is used to 'pump' (create) the 1064 / 532nm wavelengths. The outputs of the two lasers are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532nm or 1064nm wavelengths. The 532nm or 1064nm output energy is delivered to the skin through an Articulated Arm and Zoom Handpiece (HP) delivery system. There are also 3 hand pieces (Resolve), one for 1064nm and two for 532nm (low energy and high energy), which deliver a 10 x 10 array of focused spots to the skin and 1 Axicon hand piece (Resolve Fusion) for 532nm, which delivers a 10 x 10 array of focused and ring spots to the skin.
The provided document describes the Candela PicoWay Laser System (K220853) and its substantial equivalence to a predicate device (K191685). The primary difference is the addition of new indications for benign pigmented lesions. The document does not refer to the device as an "AI device" or an "algorithm," but rather a laser system. Therefore, some of the requested information regarding AI device testing (e.g., human-in-the-loop performance, effect size of human improvement with AI, training set details, expert qualifications for ground truth in a test set, adjudication methods) is not directly applicable.
However, based on the information provided, here's a summary of the acceptance criteria and the study that supports the expanded indications for the PicoWay Laser System, focusing on the clinical evidence for the new indications.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the expanded indications are implied by the clinical studies demonstrating the safety and effectiveness of the PicoWay Laser System for these conditions. The reported device performance is derived from the outcomes of these clinical studies.
| Acceptance Criteria (Implied) | Reported Device Performance (from Clinical Studies) |
|---|---|
| Expanded Indications Safety & Effectiveness: Device is safe and effective for new benign pigmented lesion indications (Nevus of Ota, café au lait macules (CALMs), melasma, and lentigines) for Fitzpatrick Skin Types I-IV, at specified wavelengths and handpieces. | General Safety: Treatments were well tolerated, and no device-related adverse events were reported in the investigator-initiated study for melasma. The systematic literature review implies satisfactory safety for the other indications as it informed the conclusion of substantial equivalence. |
| Melasma Treatment Efficacy: Statistically significant improvement in melasma. | Melasma: Statistically significant improvement (p<0.05) in mean mMASI scores at 3-month follow-up visits compared to baseline in an investigator-initiated study. Majority of subjects (≥70%) showed improvement. |
| Nevus of Ota Treatment Efficacy: Effective treatment of Nevus of Ota. | Nevus of Ota: Treatment described in identified articles, implying efficacy for FDA to accept the indication. (Specific metrics not provided in summary, but implied by inclusion). |
| CALMs Treatment Efficacy: Effective treatment of café au lait macules. | CALMs: Treatment described in identified articles, implying efficacy for FDA to accept the indication. (Specific metrics not provided in summary, but implied by inclusion). |
| Lentigines Treatment Efficacy: Effective treatment of lentigines. | Lentigines: Treatment described in identified articles, implying efficacy for FDA to accept the indication. (Specific metrics not provided in summary, but implied by inclusion). |
| Substantial Equivalence: The expanded indications do not raise any new concerns of safety or effectiveness. | The "technological comparison" and "performance data" sections argue for substantial equivalence based on identical design, function, and existing performance testing of the predicate device, with the clinical literature review supporting the safety and effectiveness of the expanded indications. |
Study Details (Relevant to Expanded Indications for Benign Pigmented Lesions)
-
Sample Size Used for the Test Set and Data Provenance:
- Systematic Literature Search: Nine articles were identified, including randomized controlled, prospective, open-label, evaluator-blinded clinical trials or retrospective evaluator-blinded studies.
- Total Subjects: 262 subjects across the identified studies.
- Nevus of Ota: n=20
- Café au lait macules (CALMs): n=32
- Melasma: n=70
- Lentigines: n=140
- Data Provenance: Studies were conducted in the USA, UK, Asia (Thailand, China), and the Middle East (Israel). The studies appear to be retrospective and prospective clinical trials.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- The document mentions "evaluator-blinded" studies, implying assessments by experts, but it does not specify the number of experts or their qualifications used to establish ground truth for each specific study or the overall literature review. However, in the context of clinical trials for dermatological conditions, "evaluator-blinded" typically implies assessment by trained clinical personnel (e.g., dermatologists, physicians, or qualified study staff) who are blinded to the treatment arm or other study parameters to ensure unbiased evaluation of treatment outcomes.
-
Adjudication Method for the Test Set:
- The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The use of "evaluator-blinded" suggests independent assessment, but the process for resolving disagreements or consolidating multiple evaluations is not detailed.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done in the context of AI assistance. This device is a laser system, not an AI diagnostic device. The clinical studies described evaluate the effectiveness of the laser treatment itself.
-
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This is a laser system, not an algorithm. Its performance is directly related to its physical operation and interaction with human tissue in a clinical setting, always with human involvement (a clinician operating the device).
-
Type of Ground Truth Used:
- The ground truth was established through clinical evaluation of treatment outcomes by clinical investigators/evaluators (presumably physicians or trained medical staff).
- For melasma, the "mean mMASI scores" (Melasma Area and Severity Index) were used, which is a standardized clinical assessment tool.
- For other lesions, efficacy is implied by the reported treatment outcomes in the cited peer-reviewed literature.
-
Sample Size for the Training Set:
- Not applicable. This is a laser device, not an AI system that undergoes training on a dataset. The "training" for such a device involves engineering design, manufacturing, and preclinical testing to ensure it meets performance specifications, followed by clinical studies to validate its safety and efficacy in humans.
-
How the Ground Truth for the Training Set was Established:
- Not applicable. See point 7. The device's "performance" is based on its physical characteristics (wavelengths, fluence, pulse duration, spot size) and the clinical outcomes observed in human subjects.
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October 13, 2022
Candela Corporation Danielle Gibboney Sr. Regulatory Affairs Specialist 251 Locke Drive Marlborough, Massachusetts 01752
Re: K220853
Trade/Device Name: PicoWay Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: September 8, 2022 Received: September 8, 2022
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 mediation-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 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) K220853
Device Name PicoWay Laser System
Indications for Use (Describe)
The PicoWay laser system is indicated for the following at the specified wavelength:
- · 532 mm: Removal of tattoos for Fitzpatrick Skin Types I-III to treat the following tattoo colors: red, yellow and orange.
- · 730 nm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue.
- · 785 mm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue.
· 1064 nm: Removal of tattoos for all Fitzpatrick Skin Types to treat the following tattoo colors: black, brown, green, blue and purple.
The Pico Way laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V and for treatment of Melasma for Fitzpatrick Skin Types I-IV.
The Resolve handpieces (532 nm, and 1064 nm) are also indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV.
The Resolve Fusion handpiece (532 nm) is indicated for benign pigmented for Fitzpatrick Skin Types I-IV.
The PicoWay laser system is indicated for the following at the specified wavelengths:
532 nm :
· Treatment of Melasma for Fitzpatrick Skin Types I-IV.
· Treatment of café au lait macules (CALMs) for Fitzpatrick Skin Types I-IV.
- · Treatment of Lentigines for Fitzpatrick Skin Types I-IV.
730 nm:
· Treatment of Lentigines for Fitzpatrick Skin Types I-IV.
1064 nm:
- · Treatment of Melasma for Fitzpatrick Skin Types I-IV.
- · Treatment of Nevus of Ota for Fitzpatrick Skin Types III-IV.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY K220853
Picoway Laser System
This summary of 510(k) submitted in accordance with the requirements of 21 CFR 807.92.
1. Date Prepared
Остовек 12, 2022
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: danielleg@candelamedical.com
-
- Product Information
Name of Device: Picoway Laser System
- Product Information
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: Picoway Laser System (K191685)
6. Device Description:
The PicoWay Laser System is a solid-state laser capable of delivering energy at wavelengths of 1064 nm, 532 nm, or 730 nm, at extremely short duration in the range of 240-500 (ps). The laser system contains one 755 nm (Alexandrite) laser head which is used to 'pump' (create) the 1064 / 532nm wavelengths. The outputs of the two lasers are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532nm or 1064nm wavelengths. The 532nm or 1064nm output energy is delivered to the skin through an Articulated Arm and Zoom Handpiece (HP) delivery system. There are also 3 hand pieces (Resolve), one for 1064nm and two for 532nm (low energy and high energy), which deliver a 10 x 10 array of focused spots to the skin and 1 Axicon hand piece (Resolve Fusion) for 532nm, which delivers a 10 x 10 array of focused and ring spots to the skin. The following handpieces are cleared to be used with Picoway Laser System
Zoom Handpieces:
●
- 532 nm
- 1064 nm
Handpieces:
- 730 nm ●
- 785 nm
Resolve Handpieces:
- 532 nm ●
- 532 nm HE ●
- . 1064 nm
Resolve Fusion Handpieces:
- 532 nm ●
- . 1064 nm
7. Intended Use and Indications for Use:
The PicoWay laser system is indicated for the following at the specified wavelength:
- 532 nm: Removal of tattoos for Fitzpatrick Skin Types I-III to treat the following tattoo ● colors: red, yellow and orange.
- 730 nm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following . tattoo colors: green and blue.
- . 785 nm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue.
- 1064 nm: Removal of tattoos for all Fitzpatrick Skin Types to treat the following tattoo . colors: black, brown, green, blue and purple.
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The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V and for treatment of Melasma for Fitzpatrick Skin Types I-IV.
The Resolve handpieces (532 nm HE, 532 nm, and 1064 nm) are also indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV.
The Resolve Fusion handpiece (532 nm) is indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The PicoWay laser system is indicated for the following at the specified wavelengths:
532 nm:
- Treatment of Melasma for Fitzpatrick Skin Types I-IV. 0
- Treatment of café au lait macules (CALMs) for Fitzpatrick Skin Types I-IV. 0
- Treatment of Lentigines for Fitzpatrick Skin Types I-IV. 0
730 nm:
- o Treatment of Lentigines for Fitzpatrick Skin Types I-IV.
1064 nm:
- Treatment of Melasma for Fitzpatrick Skin Types I-IV. o
- Treatment of Nevus of Ota for Fitzpatrick Skin Types III-IV. O
8. TECHNOLOGICAL COMPARISON:
The subject device Picoway Laser System is substantially equivalent and identical in the design, function, and intended use to the Picoway Laser System (K191685). The difference between the subject Picoway Laser System and its predicate is the additional indications for benign pigmented lesions including but not limited to: Nevus of Ota, café au lait macules (CALMs), melasma, and lentigines that this Premarket Notification is proposing. The expanded indications between the subject device and its predicate does not raise any new concerns of safety or effectiveness of the device. Thus, based on the information presented in this Premarket Notification, Picoway Laser System is substantially equivalent to its predicate Picowav Laser System (K191685). 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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| Table 1: Intended/Indication for use comparison table. | |
|---|---|
| -------------------------------------------------------- | -- |
| Name of Device:510(k)Product CodeDevice Class | Picoway Laser SystemProposedK220853GEXClass II | Picoway Laser SystemPredicateK191685GEXClass II | |
|---|---|---|---|
| Intended use /Indications: | The PicoWay laser system is indicated for the following at the specified wavelength:532 nm: Removal of tattoos for Fitzpatrick Skin Types I-III to treat the following tattoo colors: red, yellow and orange.730 nm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue.785 nm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue.1064 nm: Removal of tattoos for all Fitzpatrick Skin Types to treat the following tattoo colors: black, brown, green, blue and purple. | The PicoWay laser system is indicated for the following at the specified wavelength:532 nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors:red, yellow and orange.730 nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors:green and blue.785 nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors:green and blue.1064 nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoocolors: black, brown, green, blue and purple. | |
| The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. | The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. | ||
| The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V and for treatment of Melasma for Fitzpatrick Skin Types I-IV. | The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. | ||
| The Resolve handpieces (532 nm HE, 532 nm, and 1064 nm) are also indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV. | The Resolve handpieces (532 nm HE, 532 nm, 1064 nm) are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV. | ||
| The Resolve Fusion handpiece (532 nm) is indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. | The Resolve Fusion handpiece (1064 nm) is indicated for the treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV. | ||
| The PicoWay laser system with Zoom Handpieces is indicated for the following at the specified wavelengths: | The Resolve Fusion handpiece (532 nm) is indicated for the treatment | ||
| 532 nm: | of benign pigmented lesions in Fitzpatrick Skin Types I-IV. | ||
| Treatment of Melasma for Fitzpatrick Skin Types I-IV. Treatment of café au lait macules (CALMs) for Fitzpatrick Skin Types I-IV. Treatment of Lentigines for Fitzpatrick Skin Types I-IV. | |||
| 730 nm: | |||
| Treatment of Lentigines for Fitzpatrick Skin Types I-IV. | |||
| 1064 nm: | |||
| Treatment of Melasma for Fitzpatrick Skin Types I-IV. Treatment of Nevus of Ota for Fitzpatrick Skin Types III-IV. | |||
| Similarities/Differences | Identical to Predicate device, but with expanded indications identified in BOLD . |
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| GeneralSpecifications | Picoway Laser SystemSubject DeviceNot Assigned | Picoway Laser SystemPredicateK191685 | ||||||
|---|---|---|---|---|---|---|---|---|
| Wavelength | IDENTICAL532 nm | IDENTICAL730 nm | IDENTICAL785 nm | IDENTICAL1064 nm | IDENTICAL532 nm | IDENTICAL730 nm | IDENTICAL785 nm | IDENTICAL1064 nm |
| IDENTICAL | IDENTICAL | IDENTICAL | IDENTICAL | IDENTICAL | IDENTICAL | IDENTICAL | IDENTICAL | |
| Laser Type | Resolve: &ResolveFusionDouble Nd:YagZoom:TitaniumSapphire | Handpiece:TitaniumSapphire | Handpiece:TitaniumSapphire | Resolve & Resolve Fusion:Nd: Yag FrequencyZoom: Titanium Sapphire | Resolve: &ResolveFusionDouble Nd:Yag | Zoom:TitaniumSapphire | Zoom:TitaniumSapphire | Resolve & Resolve Fusion:Nd: Yag FrequencyZoom: Titanium Sapphire |
| Repetition Rate | IDENTICAL | IDENTICAL | ||||||
| (Hz) | Single 1, 2, 2, 4, 5, 6, 7, 8, 9, 10 Hz | Single 1, 2, 2, 4, 5, 6, 7, 8, 9, 10 HzIDENTICAL | ||||||
| Fluence Ranges | IDENTICALZoom Handpiece:2 mm: 1-00-6.25 J/cm²3 mm: 0.040-2.80 J/cm²4 mm: 0.30-1.60 J/cm²5 mm: 0.20-1.00 J/cm26 mm: 0.20-0.72 J/cm27 mm: 0.26-0.52 J/cm28 mm: 0.20- 0.40 J/cm2 | Zoom Handpiece:2 mm: 1-00-6.25 J/cm²3 mm: 0.040-2.80 J/cm²4 mm: 0.30-1.60 J/cm²5 mm: 0.20-1.00 J/cm26 mm: 0.20-0.72 J/cm27 mm: 0.26-0.52 J/cm28 mm: 0.20- 0.40 J/cm2 |
Table 2: Technological & Biological specification comparison
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| GeneralSpecifications | Picoway Laser SystemSubject DeviceNot Assigned | Picoway Laser SystemPredicateK191685 |
|---|---|---|
| 9 mm: 0.16-0.32 J/cm210 mm: 0.13-0.25 J/cm2Resolve High Energy Handpiece:0.20-1.50 mJ/µbeamResolve Low Energy Handpiece:0.16-0.30 mJ/µbeamResolve Fusion Handpiece:0.20-0.70IDENTICAL | 9 mm: 0.16-0.32 J/cm210 mm: 0.13-0.25 J/cm2Resolve High Energy Handpiece:0.20-1.50 mJ/µbeamResolve Low Energy Handpiece:0.16-0.30 mJ/µbeamResolve Fusion Handpiece:0.20-0.70IDENTICAL | |
| Pulse Duration | 240-500 picosecondIDENTICAL | 240-500 picosecondIDENTICAL |
| Spot Size (mm) | Zoom:2 to 10 in increments of 1mmResolve:6 mm x 6 mm array in 10 x 10 matrixResolve Fusion:6 mm x 6 mm array in 10 x 10 matrix | Zoom:2 to 10 in increments of 1mmResolve:6 mm x 6 mm array in 10 x 10 matrixResolve Fusion:6 mm x 6 mm array in 10 x 10 matrix |
| BIOLOGICAL CHARACTERISTICS | ||
| PatientContactingMaterial | IDENTICALAluminum | IDENTICALAluminum |
| SYSTEMS | ||
| Delivery system | IDENTICALArticulated arm with dedicate handpiece | IDENTICALArticulated arm with dedicate handpiece |
| User Interface | IDENTICALTouchscreen with GUI | IDENTICALTouchscreen with GUI |
| Electrical Power | IDENTICAL | IDENTICAL |
| GeneralSpecifications | Picoway Laser SystemSubject DeviceNot Assigned | Picoway Laser SystemPredicateK191685 |
| 200-240 VAC, 50/60 HZ, 4600 VA single | 200-240 VAC, 50/60 HZ, 4600 VA single | |
| PhysicalDimensions/Weight (Console) | IDENTICAL275 lb (125 kg) | IDENTICAL275 lb (125 kg) |
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9. Performance Data:
Performance Testing: Bench:
The performance testing of the subject PicoWay Laser System is based on the established testing previous cleared under PicoWay Laster System predicate (K191685). There are no changes in the design therefore the subject Picoway Laser System is based on the established performance testing of the device's predicate.
Performance Testing-Clinical
A systematic literature search, using PubMed, Embase and Cochrane databases, was conducted to identify peer-reviewed articles published during January 1, 2015 to May 31, 2022 in which the PicoWay Laser System was used to treat benign pigmented lesions, with any of the PicoWay Laser Handpieces at 532 nm, 730 nm, 785 nm, and 1064 nm wavelengths. A combination of MeSH terms and free-text searches for the device (picoway laser, picosecond laser) and for pigmented lesions and specific benign pigmented lesions nevus of Ota, CALM (macules) and/or melasma, were included in the search criteria. A supplemental search in ClinicalTrials.gov was performed using similar search terms to identify clinical trials with results relevant to the clinical safety and performance of the Picoway Laser System. The Literature Search methodology and findings are described in detail within the Clinical Literature Summary below.
Nine articles were identified that reported on randomized controlled, or prospective, open label, evaluator-blinded clinical trials or retrospective evaluatorblinded studies that treated at least 10 individuals in each study using the PicoWay Laser System. The studies were conducted in the USA, the UK, Asia (Thailand, China) and the Middle East (Israel) and included a total of 262 subjects (228 females, 34 males; Fitzpatrick Skin Type (FST) I-V) treated for benign pigmented lesions, including nevus of Ota (n=20), café au lait macules (n=32), melasma (n=70) and lentigines (n=140), using the PicoWay Laser System. Melasma was treated with the PicoWay Zoom handpieces (532 nm and/or 1064 nm) and the PicoWay Resolve 1064 nm handpiece alone or combined with 12 weeks of daily application of 4% hydroquinone cream. CALMs were treated with the Zoom 532 nm handpiece; nevus of Ota was treated using the PicoWay Zoom 1064 nm handpiece, and lentigines were treated with the PicoWay 730 nm handpiece and the Zoom 532 nm handpiece. The articles are identified in table 3 below.
| Article | Title | Indication | PicoWay LaserHandpiece (s) |
|---|---|---|---|
| 1 | Wong CSM, Chan MWM, Shek SYN, YeungCK & Chan HHL. Fractional 1064 nmpicosecond laser in treatment of melasmaand skin rejuvenation in Asians, a | Melasma | Melasma: (Resolve1064 nm laser) |
| Article | Title | Indication | PicoWay LaserHandpiece (s) |
| 1 | prospective study. Lasers Surg Med2021;53(8):1032-1042. | ||
| 2 | Kung KY, Shek SYN, Yeung CK, & ChanHHL. Evaluation of the safety and efficacy ofthe dual wavelength picosecond laser for thetreatment of benign pigmented lesions inAsians. Lasers Surg Med 2019;51(1):14-22. | Melasma;CALMs | Melasma: (Zoom 1064nm laser)CALM: (Zoom 532 nmlaser) |
| 3 | Chalermchai T, Rummaneethorn P. Effects ofa fractional picosecond 1,064 nm laser for thetreatment of dermal and mixed typemelasma. J Cosmet Laser Ther. 2018Jun;20(3):134-139.*article included treatement 4% hydroquinone | Melasma | Melasma: (Resolve1064 nm laser) |
| 4 | Mehrabi JN, Friedman O, Al-Niaimi F & Artzi,O. Retrospective photographic review ofnontattoo indications treated by picosecondlaser. J Cosmet Dermatol 2020;Mar;19(3):612-621. | Melasma;CALMs;Nevus of Ota | Melasma: (Resolve1064 nm laser andZoom 1064 nm or 532nm lasers)CALM: (Zoom 532 nmlaser)Nevus of Ota: (Zoom1064 nm laser)Lentigines:(Zoom 532 nm laser) |
| 5 | Yang H, Guo L, Jia G, Gong X, Wu Q, ZengR, Zhang M, Ding H, Fang F, Zheng H, Liu X,Ge Y, Yang Y, Lin T. Treatment of nevus ofOta with 1064 nm picosecond Nd:YAG laser:A retrospective study. Dermatol Ther 2021;Nov;34(6):e15152. | Nevus of Ota | Nevus of Ota: (Zoom1064 nm laser) |
| 6 | Artzi O, Mehrabi JN, Koren A, Niv R,Lapidoth M, Levi A. Picosecond 532-nmneodymium-doped yttrium aluminium garnetlaser-a novel and promising modality for thetreatment of café-au-lait macules. LasersMed Sci 2018 May;33(4):693-697. | CALMs | CALM: (Zoom 532 nmlaser) |
| 7 | Kauvar ANB, Sun R, Bhawan J, Singh G,Ugonabo N, Feng H, Schomacker K.Treatment of facial and non-facial lentigineswith a 730 nm picosecond titanium: Sapphirelaser is safe and effective. Lasers Surg Med.2022 Jan;54(1):89-97. | Lentigines | Lentigines (730 nmlaser) |
| Article | Title | Indication | PicoWay LaserHandpiece (s) |
| 8 | Vachiramon V, Namasondhi A, AnuntrangseeT, Jurairattanaporn N. Randomized,evaluator-blinded comparative study of apotassium titanyl phosphate (KTP) 532-nmpicosecond laser and an alexandrite 755-nmpicosecond laser for the treatment of solarlentigines in Asians. J Cosmet Dermatol.2022 Feb 7. | Lentigines | Lentigines (Zoom 532nm laser) |
| 9 | Vachiramon V, lamsumang W, TriyangkulsriK. Q-switched double frequency Nd:YAG532-nm nanosecond laser vs. doublefrequency Nd:YAG 532-nm picosecond laserfor the treatment of solar lentigines in Asians.Lasers Med Sci. 2018 Dec;33(9):1941-1947. | Lentigines | Lentigines (Zoom 532nm laser) |
Table 3. Identification of Clinical Articles in PicoWay literature search analysis
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Additionally, Candela identified an investigator-initiated prospective, open-label clinical study that had been conducted by Principal Investigator Eric F. Bernstein, M.D. of Main Line Center Surgery for Laser Surgery in Ardmore, PA. In this study, treatment of melasma with the PicoWay® device using the 1064nm Resolve handpiece resulted in statistically significant improvement (p<0.05) in mean mMASI scores at 3-month follow-up visits in comparison to baseline. Majority of the subjects (≥70 %) demonstrated improvement in the appearance of melasma at both followup visits. Investigator and Subject satisfaction ratings with treatment outcome were remarkably high (> 85%). Treatments were well tolerated, and there were no device-related adverse events.
10. SUBSTANTIAL EQUIVALENCE COMPARISON
When comparing the subject Picoway Laser System to the predicate device Picoway Laser System (K191685) the additional indications for use does not raise any new issues of safety and effectiveness. There are no technological changes between the subject and predicate device. The Picoway Laser System is substantially equivalent, in terms of technological characteristics, performance, and intended use to the predicate device Picoway Laser System (K191685) 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.