PICOPLUS Laser System

• K Number: K173700
• Device Name: PICOPLUS Laser System
• Manufacturer: Lutronic Corporation
• Date Cleared: 2018-06-19 ( 197 days)
• Product Code: GEX
• Regulation Number: 878.4810

Intended 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 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

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.

Predicate Devices

K172077, K163222

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser system with specific wavelengths and pulse durations for tattoo removal and treatment of pigmented lesions. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on compliance with electrical safety and electromagnetic compatibility standards, and clinical equivalence to predicate devices, without any mention of AI/ML performance metrics.

Therapeutic

Yes
The device is used for medical applications such as the removal of tattoos and the treatment of benign pigmented lesions, which are therapeutic interventions.

Diagnostic

No

Explanation: The device description and intended use clearly state that the PICOPLUS Laser System is a surgical laser instrument used for "surgical and aesthetic applications" such as tattoo removal and treatment of benign pigmented lesions. There is no mention of it being used to diagnose conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "surgical laser instrument" and includes physical components like a "laser system console, an articulated arm and attached handpieces," indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is for "surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery." This involves direct interaction with the patient's body for treatment purposes (tattoo removal, lesion treatment).
• Device Description: The device is described as a "surgical laser instrument" that delivers energy to the patient.
• Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on specimens.

The PICOPLUS Laser System is a therapeutic device used for medical procedures performed directly on the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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

Product codes

GEX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K172077, K163222

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

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

1

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 ([e-mail]) or phone [phone] 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

2

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)
------------------------------------------------------------------------------------	------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

6. 510(k) SUMMARY OR STATEMENT

The Company's 510(k) Summary for the PICOPLUS Laser System is as follows:

4

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 Corporation
Lutronic Center, 219 Sowon-ro
Haengsin-dong, Deogyang-gu
Goyang-si, Gyeonggi-do 410-220
Republic of Korea
Tel: [phone]
FAX: [phone] |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James J Childs, PhD
Clinical Science Director |
| | Lutronic Corporation
19 Fortune Drive
Billerica, MA 01821
Tel: [phone]
FAX: [phone]
Email: [e-mail] |
| Summary Preparation Date: | June 18, 2018 |

2. Names

Trade Name: PICOPLUS Laser System

Common Name: Laser Surgical Instrument

5

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

6

• 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

7

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	Max
Pulse
Energy	Spot
Size	Fluence	Handpiece	Indications for Use	Wave-
length	Max
Pulse
Energy	Spot
Size	Fluence
Handpiece
(2 ns)	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	1064
nm	800 mJ	2, 3, 4,
5, 6
mm	0.18~
10
J/cm²	Handpiece
(2 ns)	Indicated for treatment
of benign pigmented
lesions on patients with
all skin types
(Fitzpatrick I-VI); tattoo
removal for dark
colored tattoo inks and
for multicolored tattoos
containing inks on
patients with all skin
types (Fitzpatrick I-VI)	1064
nm	800 mJ	2, 2.5, 3,
3.5, 4, 5,
6, 7, 8,
9, 10
mm	10 J/cm²
(range
not
available)
	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	532
nm	300 mJ	2.3,
3.3,
4.3,
5.3
mm	0.05~
2.5
J/cm²		Indicated for treatment
of benign pigmented
lesions for Fitzpatrick
skin types I-IV; tattoo
removal with lighter
colored inks including
red and yellow inks for
Fitzpatrick skin types I-
III	532
nm	400 mJ	2, 2.5, 3,
3.5, 4, 5,
6, 7, 8,
9, 10
mm	2.5 J/cm²
(range
not
available)

8

		Lutronic Corporation PICOPLUS Laser System				Cutera Enlighten III
Handpiece	Indications for Use	Wave-
length	Max
Pulse
Energy	Spot
Size	Fluence	Handpiece	Indications for Use	Wave-
length	Max
Pulse
Energy	Spot
Size	Fluence
Handpiece
2
(2 ns)	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	1064
nm	800 mJ	6, 7, 8,
9, 10
mm	0.07~
2.8
J/cm²	Handpiece
(2 ns)	Indicated for treatment
of benign pigmented
lesions on patients with
all skin types
(Fitzpatrick I-VI); tattoo
removal for dark
colored tattoo inks and
for multicolored tattoos
containing inks on
patients with all skin
types (Fitzpatrick I-VI)	1064
nm	800 mJ	2, 2.5, 3,
3.5, 4, 5,
6, 7, 8,
9, 10
mm	10 J/cm²
(range
not
available)
	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	532
nm	300 mJ	4.3,
5.3,
6.5, 8
mm	0.02~
2.0
J/cm²		Indicated for treatment
of benign pigmented
lesions on patients with
Fitzpatrick skin types I-
IV; tattoo removal for
lighter colored tattoo
inks, including red and
yellow inks, on patients
with Fitzpatrick skin
types I-III	532
nm	400 mJ	2, 2.5, 3,
3.5, 4, 5,
6, 7, 8,
9, 10
mm	2.5 J/cm²
(range
not
available)

Table 1a. Comparison of IFUs and device specifications at Nanosecond Pulse Durations (Cont.)

9

10

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
Handpiece
1 (450 ps)	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.
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	1064 nm

532 nm | Handpiece
(450 ps) | Indicated for removal of
tattoos on all Fitzpatrick
skin types I- VI with
following colors: black,
brown, green, blue, and
purple.
Indicated for treatment of
benign pigmented lesions
on Fitzpatrick types I-IV
Indicated for removal of
tattoos on Fitzpatrick
skin types I-III with the
following colors: red,
yellow and orange.
Indicated for treatment of
benign pigmented lesions
on Fitzpatrick Skin Types
I-IV | 1064 nm

532 nm |
| Max
Pulse
Energy | Spot
Size | Fluence
(range) | Max
Pulse
Energy | Spot
Size | Fluence |
| 800 mJ

300 mJ | 3, 4, 5,
6 mm

3.3, 4.3,
5.3 mm | 0.18 -
5.6 J/cm²

0.05 -
2.8 J/cm² | 800 mJ

300 mJ | 3, 4.5,
6, 7.5
9, 10.5 mm

3, 4.5,
6, 7.5
9, 10.5 mm | 5.6 J/cm²
(range not
available)

2.8 J/cm²
(range not
available) |

11

Comparison of device specifications at Picosecond Pulse Duration
Lutronic Corporation PICOPLUS Laser System						Discovery Pico Family
Handpiece	Indications for Use	Wave-
length	Max
Pulse
Energy	Spot
Size	Fluence
(range)	Handpiece	Indications for Use	Wave-
length	Max
Pulse
Energy	Spot
Size	Fluence
Handpiece
2 (450
ps)	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	1064
nm	800 mJ	6, 7, 8,
9, 10
mm	0.07 -
2.8
J/cm²	Handpiece
(450 ps)	Indicated for removal of
tattoos on all Fitzpatrick
skin types I-VI with
following colors: black,
brown, green, blue, and
purple.
Indicated for treatment of
benign pigmented lesions
on Fitzpatrick types I-IV	1064
nm	800 mJ	3, 4.5,
6, 7.5
9, 10.5
mm	5.6 J/cm²
(range
not
available)
	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	532
nm	300 mJ	4.3, 5.3,
6.5, 8
mm	0.02 -
2.0
J/cm²		Indicated for removal of
tattoos on Fitzpatrick
skin types I-III with the
following colors: red,
yellow and orange.
Indicated for treatment of
benign pigmented lesions
on Fitzpatrick Skin Types
I-IV	532
nm	300 mJ	3, 4.5,
6, 7.5
9, 10.5
mm	2.8 J/cm²
(range
not
available)

Table 1b. Comparison of IFUs and device specifications at Picosecond Pulse Durations (Cont.)

12

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

13

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.