(204 days)
Picoway Laser System (K191685)
Not Found
No
The summary describes a laser system with different wavelengths and handpieces for various skin treatments. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies are based on clinical trials and literature review, not on training or testing AI/ML models.
Yes
The device is indicated for the treatment of various medical conditions, including removal of tattoos, benign pigmented lesions, acne scars, melasma, café au lait macules, lentigines, nevus of Ota, and wrinkles. These are all conditions that affect the structure or function of the body, and the device is intended to treat or prevent them.
No
Explanation: The device is a laser system indicated for therapeutic purposes such as tattoo removal, benign pigmented lesion removal, treatment of acne scars, wrinkles, melasma, café au lait macules (CALMs), and lentigines. It does not perform any diagnostic functions.
No
The device description clearly describes a physical laser system with multiple hardware components (laser heads, articulated arm, handpieces). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The PicoWay Laser System is a laser system designed to deliver energy to the skin for therapeutic purposes, specifically tattoo removal and treatment of various skin conditions (pigmented lesions, acne scars, melasma, wrinkles).
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with the skin.
- Intended Use: The stated intended uses are all related to treating conditions on the skin surface, not diagnosing conditions through laboratory analysis of biological samples.
Therefore, the PicoWay Laser System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Nine articles were identified that reported on randomized controlled, or prospective, open label, evaluator-blinded clinical trials or retrospective evaluator-blinded 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.
Additionally, Candela identified an investigator-initiated prospective, open-label clinical study conducted by Principal Investigator Eric F. Bernstein, M.D. In this study, treatment of melasma with the PicoWay® device using the 1064nm Resolve handpiece resulted in statistically significant improvement (p=70 %) demonstrated improvement in the appearance of melasma at both follow-up 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.
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.
Picoway Laser System (K191685)
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.
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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
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 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 Code
Device Class | Picoway Laser System
Proposed
K220853
GEX
Class II | Picoway Laser System
Predicate
K191685
GEX
Class 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 tattoo
colors: 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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| General
Specifications | Picoway Laser System
Subject Device
Not Assigned | | | | Picoway Laser System
Predicate
K191685 | | | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-------------------------------|---------------------------------------------------------------------------|
| Wavelength | IDENTICAL
532 nm | IDENTICAL
730 nm | IDENTICAL
785 nm | IDENTICAL
1064 nm | IDENTICAL
532 nm | IDENTICAL
730 nm | IDENTICAL
785 nm | IDENTICAL
1064 nm |
| | IDENTICAL | IDENTICAL | IDENTICAL | IDENTICAL | IDENTICAL | IDENTICAL | IDENTICAL | IDENTICAL |
| Laser Type | Resolve: &
Resolve
Fusion
Double Nd:
Yag
Zoom:
Titanium
Sapphire | Handpiece:
Titanium
Sapphire | Handpiece:
Titanium
Sapphire | Resolve & Resolve Fusion:
Nd: Yag Frequency
Zoom: Titanium Sapphire | Resolve: &
Resolve
Fusion
Double Nd:
Yag | Zoom:
Titanium
Sapphire | Zoom:
Titanium
Sapphire | Resolve & Resolve Fusion:
Nd: Yag Frequency
Zoom: 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 Hz
IDENTICAL | | | |
| Fluence Ranges | IDENTICAL
Zoom Handpiece:
2 mm: 1-00-6.25 J/cm²
3 mm: 0.040-2.80 J/cm²
4 mm: 0.30-1.60 J/cm²
5 mm: 0.20-1.00 J/cm2
6 mm: 0.20-0.72 J/cm2
7 mm: 0.26-0.52 J/cm2
8 mm: 0.20- 0.40 J/cm2 | | | | Zoom Handpiece:
2 mm: 1-00-6.25 J/cm²
3 mm: 0.040-2.80 J/cm²
4 mm: 0.30-1.60 J/cm²
5 mm: 0.20-1.00 J/cm2
6 mm: 0.20-0.72 J/cm2
7 mm: 0.26-0.52 J/cm2
8 mm: 0.20- 0.40 J/cm2 | | | |
Table 2: Technological & Biological specification comparison
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| General
Specifications | Picoway Laser System
Subject Device
Not Assigned | Picoway Laser System
Predicate
K191685 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 9 mm: 0.16-0.32 J/cm2
10 mm: 0.13-0.25 J/cm2
Resolve High Energy Handpiece:
0.20-1.50 mJ/µbeam
Resolve Low Energy Handpiece:
0.16-0.30 mJ/µbeam
Resolve Fusion Handpiece:
0.20-0.70
IDENTICAL | 9 mm: 0.16-0.32 J/cm2
10 mm: 0.13-0.25 J/cm2
Resolve High Energy Handpiece:
0.20-1.50 mJ/µbeam
Resolve Low Energy Handpiece:
0.16-0.30 mJ/µbeam
Resolve Fusion Handpiece:
0.20-0.70
IDENTICAL |
| Pulse Duration | 240-500 picosecond
IDENTICAL | 240-500 picosecond
IDENTICAL |
| Spot Size (mm) | Zoom:
2 to 10 in increments of 1mm
Resolve:
6 mm x 6 mm array in 10 x 10 matrix
Resolve Fusion:
6 mm x 6 mm array in 10 x 10 matrix | Zoom:
2 to 10 in increments of 1mm
Resolve:
6 mm x 6 mm array in 10 x 10 matrix
Resolve Fusion:
6 mm x 6 mm array in 10 x 10 matrix |
| BIOLOGICAL CHARACTERISTICS | | |
| Patient
Contacting
Material | IDENTICAL
Aluminum | IDENTICAL
Aluminum |
| SYSTEMS | | |
| Delivery system | IDENTICAL
Articulated arm with dedicate handpiece | IDENTICAL
Articulated arm with dedicate handpiece |
| User Interface | IDENTICAL
Touchscreen with GUI | IDENTICAL
Touchscreen with GUI |
| Electrical Power | IDENTICAL | IDENTICAL |
| General
Specifications | Picoway Laser System
Subject Device
Not Assigned | Picoway Laser System
Predicate
K191685 |
| | 200-240 VAC, 50/60 HZ, 4600 VA single | 200-240 VAC, 50/60 HZ, 4600 VA single |
| Physical
Dimensions
/Weight (Console) | IDENTICAL
275 lb (125 kg) | IDENTICAL
275 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 Laser
Handpiece (s) |
|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Wong CSM, Chan MWM, Shek SYN, Yeung
CK & Chan HHL. Fractional 1064 nm
picosecond laser in treatment of melasma
and skin rejuvenation in Asians, a | Melasma | Melasma: (Resolve
1064 nm laser) |
| Article | Title | Indication | PicoWay Laser
Handpiece (s) |
| 1 | prospective study. Lasers Surg Med
2021;53(8):1032-1042. | | |
| 2 | Kung KY, Shek SYN, Yeung CK, & Chan
HHL. Evaluation of the safety and efficacy of
the dual wavelength picosecond laser for the
treatment of benign pigmented lesions in
Asians. Lasers Surg Med 2019;51(1):14-22. | Melasma;
CALMs | Melasma: (Zoom 1064
nm laser)
CALM: (Zoom 532 nm
laser) |
| 3 | Chalermchai T, Rummaneethorn P. Effects of
a fractional picosecond 1,064 nm laser for the
treatment of dermal and mixed type
melasma. J Cosmet Laser Ther. 2018
Jun;20(3):134-139.
*article included treatement 4% hydroquinone | Melasma | Melasma: (Resolve
1064 nm laser) |
| 4 | Mehrabi JN, Friedman O, Al-Niaimi F & Artzi,
O. Retrospective photographic review of
nontattoo indications treated by picosecond
laser. J Cosmet Dermatol 2020;
Mar;19(3):612-621. | Melasma;
CALMs;
Nevus of Ota | Melasma: (Resolve
1064 nm laser and
Zoom 1064 nm or 532
nm lasers)
CALM: (Zoom 532 nm
laser)
Nevus of Ota: (Zoom
1064 nm laser)
Lentigines:
(Zoom 532 nm laser) |
| 5 | Yang H, Guo L, Jia G, Gong X, Wu Q, Zeng
R, Zhang M, Ding H, Fang F, Zheng H, Liu X,
Ge Y, Yang Y, Lin T. Treatment of nevus of
Ota with 1064 nm picosecond Nd:YAG laser:
A retrospective study. Dermatol Ther 2021;
Nov;34(6):e15152. | Nevus of Ota | Nevus of Ota: (Zoom
1064 nm laser) |
| 6 | Artzi O, Mehrabi JN, Koren A, Niv R,
Lapidoth M, Levi A. Picosecond 532-nm
neodymium-doped yttrium aluminium garnet
laser-a novel and promising modality for the
treatment of café-au-lait macules. Lasers
Med Sci 2018 May;33(4):693-697. | CALMs | CALM: (Zoom 532 nm
laser) |
| 7 | Kauvar ANB, Sun R, Bhawan J, Singh G,
Ugonabo N, Feng H, Schomacker K.
Treatment of facial and non-facial lentigines
with a 730 nm picosecond titanium: Sapphire
laser is safe and effective. Lasers Surg Med.
2022 Jan;54(1):89-97. | Lentigines | Lentigines (730 nm
laser) |
| Article | Title | Indication | PicoWay Laser
Handpiece (s) |
| 8 | Vachiramon V, Namasondhi A, Anuntrangsee
T, Jurairattanaporn N. Randomized,
evaluator-blinded comparative study of a
potassium titanyl phosphate (KTP) 532-nm
picosecond laser and an alexandrite 755-nm
picosecond laser for the treatment of solar
lentigines in Asians. J Cosmet Dermatol.
2022 Feb 7. | Lentigines | Lentigines (Zoom 532
nm laser) |
| 9 | Vachiramon V, lamsumang W, Triyangkulsri
K. Q-switched double frequency Nd:YAG
532-nm nanosecond laser vs. double
frequency Nd:YAG 532-nm picosecond laser
for the treatment of solar lentigines in Asians.
Lasers Med Sci. 2018 Dec;33(9):1941-1947. | Lentigines | Lentigines (Zoom 532
nm 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 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.