(197 days)
The PICOPLUS Laser System is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery as follows:
The 1064 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for:
· Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
· Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
The 532 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for:
- · Removal of tattoos for Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- · Treatment of benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The 1064 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for:
- · Treatment of benign pigmented lesions on Fitzpatrick skin type I-VI
- Removal of dark and multi-colored tattoos containing dark colored tattoo inks on Fitzpatrick skin types 1-VI
The 532 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for:
- · Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV
- Removal of lighter colored tattoo inks, including red and yellow inks, on Fitzpatrick skin types I-III
The PICOPLUS Laser System is a surgical laser instrument. The PICOPLUS Laser System is designed and manufactured in accordance with 21 CFR 820 (with emphasis on 820.30) and 21 CFR 1040 for medical devices in order to insure user safety and durability of use.
The PICOPLUS Laser System is a laser system, delivering energy at wavelengths of 1064 nm and 532 nm, both at pulse durations of 450 picoseconds (ps) and 2 nanoseconds (ns). The laser system console, an articulated arm and attached handpieces.
The provided text describes a 510(k) premarket notification for the PICOPLUS Laser System and asserts its substantial equivalence to predicate devices. However, it explicitly states that no clinical performance data was provided for the PICOPLUS Laser System itself because it is considered equivalent to previously cleared predicate devices. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria for the PICOPLUS Laser System is largely unavailable in the provided document.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as specific, measurable criteria for the PICOPLUS Laser System. The acceptance is based on substantial equivalence to predicate devices.
- Reported Device Performance: No clinical performance data is reported for the PICOPLUS Laser System. The document states: "No performance data has been provided since the PICOPLUS Laser System is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable, as no clinical performance data was provided for the PICOPLUS Laser System itself.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable, as no clinical performance data was provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical performance data was provided.
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
- Not applicable. The PICOPLUS Laser System is a laser surgical instrument, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable, as no clinical performance data was provided.
8. The sample size for the training set
- Not applicable, as no clinical performance data was provided, and the device is not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable.
Summary based on the provided text:
The PICOPLUS Laser System's acceptance is based on a claim of substantial equivalence to two legally marketed predicate devices: the Cutera Enlighten III Laser System (K172077) and the Quanta System S.P.A. Discovery Pico Family (K163222). The applicant argues that the PICOPLUS device shares the "same intended use and Indications for Use statement" and that technological differences are "minor."
The documentation states that the PICOPLUS Laser System passed bench testing for compliance with applicable standards, including ISO 13485:2003, ISO 60601-1 for electrical safety, and IEC 60601-1-2 for electromagnetic compatibility. However, no clinical performance data was submitted for the PICOPLUS Laser System itself. The FDA's determination of substantial equivalence implies that the agency found the device to be as safe and effective as the predicate devices without requiring new clinical studies for this specific device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 19, 2018
Lutronic Corporation Dr. James Childs Clinical Science Director, Lutronic Global 19 Fortune Drive Billerica, MA 01821
Re: K173700
Trade/Device Name: PICOPLUS 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: May 18, 2018 Received: May 18, 2018
Dear Dr. James Childs:
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. 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 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); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173700
Device Name PICOPLUS Laser System
Indications for Use (Describe)
The PICOPLUS Laser System is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery as follows:
The 1064 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for:
· Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
· Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
The 532 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for:
- · Removal of tattoos for Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- · Treatment of benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The 1064 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for:
- · Treatment of benign pigmented lesions on Fitzpatrick skin type I-VI
- Removal of dark and multi-colored tattoos containing dark colored tattoo inks on Fitzpatrick skin types 1-VI
The 532 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for:
- · Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV
- Removal of lighter colored tattoo inks, including red and yellow inks, on Fitzpatrick skin types I-III
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) |
|---|---|
| ------------------------------------------------------------------------------------ | ------------------------------------------------------------ |
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6. 510(k) SUMMARY OR STATEMENT
The Company's 510(k) Summary for the PICOPLUS Laser System is as follows:
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510(k) Summary
Lutronic Corporation PICOPLUS Laser System
This 510(k) Summary is being submitted in accordance with 21 CFR § 807.92.
1. General Information
| Applicant: | Lutronic CorporationLutronic Center, 219 Sowon-roHaengsin-dong, Deogyang-guGoyang-si, Gyeonggi-do 410-220Republic of KoreaTel: (82) 31-908-3440FAX: (82) 31-907-3440 |
|---|---|
| Contact Person: | James J Childs, PhDClinical Science Director |
| Lutronic Corporation19 Fortune DriveBillerica, MA 01821Tel: 508-446-1126FAX: 781-262-0647Email: jchilds@lutronic.com | |
| Summary Preparation Date: | June 18, 2018 |
2. Names
Trade Name: PICOPLUS Laser System
Common Name: Laser Surgical Instrument
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Classification Name:
Powered Laser Surgical Instrument Product Code: GEX 21 CFR § 878.4810 Panel: General & Plastic Surgery
3. Predicate Devices
Cutera Enlighten III Laser System (K172077) Quanta System S.P.A. Discovery Pico Family (K163222)
4. Device Description
The PICOPLUS Laser System is a surgical laser instrument. The PICOPLUS Laser System is designed and manufactured in accordance with 21 CFR 820 (with emphasis on 820.30) and 21 CFR 1040 for medical devices in order to insure user safety and durability of use.
The PICOPLUS Laser System is a laser system, delivering energy at wavelengths of 1064 nm and 532 nm, both at pulse durations of 450 picoseconds (ps) and 2 nanoseconds (ns). The laser system console, an articulated arm and attached handpieces.
5. Indications for Use
The PICOPLUS Laser System is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery as follows:
The 532 nm wavelength and 450 pico-second pulse duration of the PICOPLUS system is indicated for
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- Removal of tattoos for Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange. .
- Treatment of benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. .
The 1064 nm wavelength and 450 pico-second pulse duration of the PICOPLUS system is indicated for:
- Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, . blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. .
The 1064 nm wavelength and nanosecond pulse duration of the PICOPLUS system is indicated for:
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-VI .
- Removal of dark and multi-colored tattoos containing dark colored tattoo inks on Fitzpatrick skin types I-VI .
The 532 nm wavelength and nanosecond pulse duration of the PICOPLUS system is indicated for:
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV .
- . Removal of lighter colored tattoo inks, including red and yellow inks, on Fitzpatrick skin types I-III
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6. Substantial Equivalence
Tables 1a & 1b below compare the device specifications for each Indication for Use of the Subject and Predicate devices.
Table 1a. Comparison of IFUs and device specifications at Nanosecond Pulse Durations
(Note the Predicate device IFUs and device specifications table or side-by-side comparison to the Subject device's Hand 2.)
| Comparison of device specifications at Nanosecond Pulse Duration | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Lutronic Corporation PICOPLUS Laser System | Cutera Enlighten III | ||||||||||
| Handpiece | Indications for Use | Wave-length | MaxPulseEnergy | SpotSize | Fluence | Handpiece | Indications for Use | Wave-length | MaxPulseEnergy | SpotSize | Fluence |
| Handpiece(2 ns) | Indicated for:• Treatment of benignpigmented lesions onFitzpatrick skin type I-VI• Removal of dark andmulti-colored tattooscontaining darkcolored tattoo inks onFitzpatrick skin types1-VI | 1064nm | 800 mJ | 2, 3, 4,5, 6mm | 0.18~10J/cm² | Handpiece(2 ns) | Indicated for treatmentof benign pigmentedlesions on patients withall skin types(Fitzpatrick I-VI); tattooremoval for darkcolored tattoo inks andfor multicolored tattooscontaining inks onpatients with all skintypes (Fitzpatrick I-VI) | 1064nm | 800 mJ | 2, 2.5, 3,3.5, 4, 5,6, 7, 8,9, 10mm | 10 J/cm²(rangenotavailable) |
| Indicated for:• Treatment of benignpigmented lesions onFitzpatrick skin types I-IV• Removal of lightercolored tattoo inks,including red and yellowinks, on Fitzpatrick skintypes I-III | 532nm | 300 mJ | 2.3,3.3,4.3,5.3mm | 0.05~2.5J/cm² | Indicated for treatmentof benign pigmentedlesions for Fitzpatrickskin types I-IV; tattooremoval with lightercolored inks includingred and yellow inks forFitzpatrick skin types I-III | 532nm | 400 mJ | 2, 2.5, 3,3.5, 4, 5,6, 7, 8,9, 10mm | 2.5 J/cm²(rangenotavailable) |
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| Lutronic Corporation PICOPLUS Laser System | Cutera Enlighten III | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Handpiece | Indications for Use | Wave-length | MaxPulseEnergy | SpotSize | Fluence | Handpiece | Indications for Use | Wave-length | MaxPulseEnergy | SpotSize | Fluence |
| Handpiece2(2 ns) | Indicated for:• Treatment of benignpigmented lesions onFitzpatrick skin type I-VI• Removal of dark andmulti-colored tattooscontaining darkcolored tattoo inks onFitzpatrick skin types1-VI | 1064nm | 800 mJ | 6, 7, 8,9, 10mm | 0.07~2.8J/cm² | Handpiece(2 ns) | Indicated for treatmentof benign pigmentedlesions on patients withall skin types(Fitzpatrick I-VI); tattooremoval for darkcolored tattoo inks andfor multicolored tattooscontaining inks onpatients with all skintypes (Fitzpatrick I-VI) | 1064nm | 800 mJ | 2, 2.5, 3,3.5, 4, 5,6, 7, 8,9, 10mm | 10 J/cm²(rangenotavailable) |
| Indicated for:• Treatment of benignpigmented lesions onFitzpatrick skin types I-IV• Removal of lightercolored tattoo inks,including red and yellowinks, on Fitzpatrick skintypes I-III | 532nm | 300 mJ | 4.3,5.3,6.5, 8mm | 0.02~2.0J/cm² | Indicated for treatmentof benign pigmentedlesions on patients withFitzpatrick skin types I-IV; tattoo removal forlighter colored tattooinks, including red andyellow inks, on patientswith Fitzpatrick skintypes I-III | 532nm | 400 mJ | 2, 2.5, 3,3.5, 4, 5,6, 7, 8,9, 10mm | 2.5 J/cm²(rangenotavailable) |
Table 1a. Comparison of IFUs and device specifications at Nanosecond Pulse Durations (Cont.)
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Table 1b. Comparison of IFUs and device specifications at Picosecond Pulse Durations (Cont.)
(Note the Predicate device IFUs and device specifications table-by-side comparison to the Subject device's Hand 2.
| Comparison of device specifications at Picosecond Pulse Duration | |||||
|---|---|---|---|---|---|
| Lutronic Corporation PICOPLUS Laser System | Discovery Pico Family | ||||
| Handpiece | Indications for Use | Wave-length | Handpiece | Indications for Use | Wave-length |
| Handpiece1 (450 ps) | Indicated for:• Removal of tattooson all skin type(Fitzpatrick skintypes I-VI) with thefollowing tattoocolors: black,brown, green, blueand purple.Indicated for:• Removal of tattoos forFitzpatrick skin types I-III with the followingtattoo colors: red,yellow and orange.• Treatment of benignpigmented lesionsremoval for FitzpatrickSkin Types I-IV | 1064 nm532 nm | Handpiece(450 ps) | Indicated for removal oftattoos on all Fitzpatrickskin types I- VI withfollowing colors: black,brown, green, blue, andpurple.Indicated for treatment ofbenign pigmented lesionson Fitzpatrick types I-IVIndicated for removal oftattoos on Fitzpatrickskin types I-III with thefollowing colors: red,yellow and orange.Indicated for treatment ofbenign pigmented lesionson Fitzpatrick Skin TypesI-IV | 1064 nm532 nm |
| MaxPulseEnergy | SpotSize | Fluence(range) | MaxPulseEnergy | SpotSize | Fluence |
| 800 mJ300 mJ | 3, 4, 5,6 mm3.3, 4.3,5.3 mm | 0.18 -5.6 J/cm²0.05 -2.8 J/cm² | 800 mJ300 mJ | 3, 4.5,6, 7.59, 10.5 mm3, 4.5,6, 7.59, 10.5 mm | 5.6 J/cm²(range notavailable)2.8 J/cm²(range notavailable) |
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| Comparison of device specifications at Picosecond Pulse Duration | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Lutronic Corporation PICOPLUS Laser System | Discovery Pico Family | ||||||||||
| Handpiece | Indications for Use | Wave-length | MaxPulseEnergy | SpotSize | Fluence(range) | Handpiece | Indications for Use | Wave-length | MaxPulseEnergy | SpotSize | Fluence |
| Handpiece2 (450ps) | Indicated for:• Removal of tattooson all skin type(Fitzpatrick skintypes I-VI) with thefollowing tattoocolors: black,brown, green, blueand purple.• Treatment of benignpigmented lesions onFitzpatrick skin types I-IV | 1064nm | 800 mJ | 6, 7, 8,9, 10mm | 0.07 -2.8J/cm² | Handpiece(450 ps) | Indicated for removal oftattoos on all Fitzpatrickskin types I-VI withfollowing colors: black,brown, green, blue, andpurple.Indicated for treatment ofbenign pigmented lesionson Fitzpatrick types I-IV | 1064nm | 800 mJ | 3, 4.5,6, 7.59, 10.5mm | 5.6 J/cm²(rangenotavailable) |
| Indicated for:• Removal of tattoos forFitzpatrick skin types I-III with the followingtattoo colors: red,yellow and orange.• Treatment of benignpigmented lesionsremoval for FitzpatrickSkin Types I-IV | 532nm | 300 mJ | 4.3, 5.3,6.5, 8mm | 0.02 -2.0J/cm² | Indicated for removal oftattoos on Fitzpatrickskin types I-III with thefollowing colors: red,yellow and orange.Indicated for treatment ofbenign pigmented lesionson Fitzpatrick Skin TypesI-IV | 532nm | 300 mJ | 3, 4.5,6, 7.59, 10.5mm | 2.8 J/cm²(rangenotavailable) |
Table 1b. Comparison of IFUs and device specifications at Picosecond Pulse Durations (Cont.)
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The PICOPLUS Laser System shares the same indications for use, device operation, technical and functional capabilities. The devices' fluences for the 1064 nm and 532 nm wavelengths at both 450 ps and 2 ns pulse durations are all the same.
Therefore the handpieces of the Subject device are substantially equivalent to the corresponding handpieces of the Predicate devices for the Indications for Use.
7. Performance Data
The Company's Performance Data for the PICOPLUS Laser System is as follows:
Bench Testing
The PICOPLUS Laser System complies with all applicable standards, including ISO 13485:2003, ISO 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility.
Clinical Testing
No performance data has been provided since the PICOPLUS Laser System is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness.
8. Conclusion
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The PICOPLUS Laser System and the legally marketed Cutera Enlighten III Laser System cleared under 510(k) number K172077 and the legally marketed Quanta System S.P.A. Discovery Pico Family cleared under 510(k) number K163222, have the same intended use and Indications for Use statement. While the technological characteristics differ between the two systems, the differences have been established to be minor. Performance testing data established that the PICOPLUS Laser System is safe and effective as the legally marked predicate devices and that the PICOPLUS Laser System does not raise any different questions of safety and effectiveness than the predicate. On this basis and in accordance with 21 CFR§ 807.100(b), the PICOPLUS Laser System is substantially equivalent to the Cutera Enlighten III Laser System and the Quanta System S.P.A. Discovery Pico Family and can be legally marketed in the U.S.
§ 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.