The PicoLazer laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

1064 nm
The 1064 nm wavelength of the PicoLazer laser system is 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 dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)

532 nm

The 532 nm wavelength of the PicoLazer laser system is indicated for:
treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III
tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III

Device Description

The Rohrer Aesthetics, LLC PicoLazer™ laser system is a dual-wavelength (532 and 1064 nm) Nd:YAG laser system that offers a 450-picosecond pulse duration that produces a maximum energy of 500mJ at 1064nm and 250mJ at 532nm.

The PicoLazer laser system consists of a system console, an articulated arm, a laser handpiece, a footswitch, and a remote interlock plug. Other components necessary for operation, such as power cables, are also included.

AI/ML Overview

This document is a 510(k) Summary for the PicoLazer Multi-wavelength Laser (K192583). It aims to demonstrate substantial equivalence to legally marketed predicate devices, not primarily to prove clinical performance through a comparative effectiveness study with specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details for proving the device meets them, especially in the context of AI/human reader performance, is not applicable to this kind of FDA submission.

Here's a breakdown of the provided information in relation to your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: For a 510(k) submission like this, the "acceptance criteria" are typically demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. Specific quantitative clinical performance acceptance criteria (e.g., sensitivity, specificity, or human reader improvement with AI) are not usually part of a substantial equivalence claim for a laser system cleared through the 510(k) pathway, especially when clinical studies are not required.
Reported Device Performance: Instead of clinical performance metrics, the document reports on several performance tests related to safety and electromagnetic compatibility (EMC), which are the typical "performance data" for non-AI medical devices cleared through substantial equivalence. These are:
- IEC 60601-1 Test for Medical Electrical equipment (General Requirements for basic safety and essential performance)
- IEC 60601-1-2 Test for Medical Equipment (General Requirements for basic safety and essential performance: electromagnetic compatibility)
- IEC 60601-2-22 Medical Electrical Equipment (Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser Equipment)
- IEC 60825-1 Safety of laser products - Part 1 (Equipment classification, and requirements)
The document states these tests were "performed in support of the substantial equivalence determination," implying they met the relevant standards, but it doesn't provide specific numerical results or pass/fail thresholds for these tests.

2. Sample size used for the test set and the data provenance

Not Applicable. This submission is for a laser device, not an AI/Software as a Medical Device (SaMD) that typically uses test sets of diagnostic images. The performance data is based on compliance with electrical and laser safety standards, not a clinical test set of patient data.
The document explicitly states: "A human clinical study was not required as the device is substantially equivalent to the predicate devices."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No clinical test set requiring expert-established ground truth was used for this 510(k) submission.

4. Adjudication method for the test set

Not Applicable. No clinical test set requiring adjudication was used.

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. No MRMC study was done, as this is a laser device that directly performs a treatment, not an AI system assisting human readers in diagnosis or interpretation. The document explicitly states "A human clinical study was not required".

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is not an AI algorithm; it's a physical laser system.

7. The type of ground truth used

Not Applicable. For a device like this, "ground truth" typically refers to the device's technical specifications and adherence to safety standards, which are verified through engineering tests rather than clinical outcomes or expert consensus on medical images.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established

Not Applicable. This is not an AI/machine learning device.

Summary of Relevant Information from the Document:

The provided document demonstrates that the PicoLazer Laser System's clearance is based on substantial equivalence to existing predicate devices (PicoWay Laser System K170597 and PicoCare Family K181272).

Key points for Substantial Equivalence:
- Intended Use: The PicoLazer's intended use ("surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery") is compared and found similar to the predicate devices.
- Indications for Use: Detailed comparisons of the specific indications for the 1064nm and 532nm wavelengths (e.g., treatment of benign pigmented lesions, tattoo removal for various ink colors and Fitzpatrick skin types) are provided and found to be substantially equivalent to the predicate devices.
- Technological Characteristics: A direct comparison table is provided for technical specifications (Wavelength, Laser Type, Max Energy, Peak Power, Spot Size, Pulse Duration, Pulse Repetition rate) and physical specifications (Console Weight, Console Size, Voltage, Current, Frequency). While not identical, the applicant argues these differences do not raise new questions of safety or effectiveness.
- Performance Data: Non-clinical performance testing (compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1) was conducted to ensure basic safety and essential performance, electromagnetic compatibility, and laser safety. No detailed numerical results from these tests are provided in this summary document, only that the tests were performed.
- Clinical Studies: The document explicitly states: "A human clinical study was not required as the device is substantially equivalent to the predicate devices." This means the FDA did not require clinical evidence of efficacy or safety beyond the substantial equivalence argument and non-clinical testing.

Summary

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Rohrer Aesthetics, LLC Mark Rohrer President 105 Citation Court Homewood, Alabama 35209

Re: K192583

Trade/Device Name: PicoLazer 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: December 17, 2019 Received: December 18, 2019

Dear Mark Rohrer:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

Jessica Mavadia-Shukla Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192583

Device Name

PicoLazer

Indications for Use (Describe)

The PicoLazer laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

1064 nm

The 1064 nm wavelength of the PicoLazer laser system is 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 dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)

532 nm

The 532 nm wavelength of the PicoLazer laser system is indicated for:
· treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III
· tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III

Type of Use (Select one or both, as applicable)

Restricted Use (Part 21 CFR 201 Subpart D)	☑
Over-The-Counter Use (21 CFR 201 Subpart G)	☐

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary PicoLazer Multi-wavelength Laser K192583

This 510(K) Summary of safety and effectiveness for the PicoLazer Multi-wavelength Laser is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

Applicant:	Rohrer Aesthetics, LLC
Address:	Rohrer Aesthetics, LLC105 Citation CourtBirmingham, AL 35209
Contact Person:	Mr. Mark Rohrer
Telephone:	205-356-1172 - phonemrohrer@rohreraesthetics.com
Preparation Date:	September 15, 2019
Device Trade Name:	PicoLazer Laser System
Common Name:	Surgical Powered Lasers and Delivery Devices/Hand pieceAccessories
Regulation Name:	Laser surgical instrument for use in general andplastic surgery and dermatology
Regulation Number:	21 CFR 878.4810 (Product Code: GEX)
Legally Marketed Predicate Device1:	PicoCare Family manufactured by Won Tech Co Ltd
510(K) number:	K181272
Legally Marketed Predicate Device 2:	PicoWay Laser System manufactured by Syneron CandelaCorporation
510(K) number:	K170597
Regulatory Class:	Class II Prescription Use
Description of the PicoLazer Multi-wavelength Laser:	The Rohrer Aesthetics, LLC PicoLazer™ laser system is adual-wavelength (532 and 1064 nm) Nd:YAG laser systemthat offers a 450-picosecond pulse duration that produces amaximum energy of 500mJ at 1064nm and 250mJ at532nm.The PicoLazer laser system consists of a system console,an articulated arm, a laser handpiece, a footswitch, and aremote interlock plug. Other components necessary foroperation, such as power cables, are also included.

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510(K) Summary PicoLazer Multi-wavelength Laser

Indication for Use:	The PicoLazer system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
	1064nm:The 1064nm wavelength of the PicoLazer laser system is indicated for:
	treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-VI.tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)
	532nm:The 532nm wavelength of the PicoLazer laser system is indicated for:
	treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-IIItattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III
Performance Data:	The following performance data was provided in support of the substantial equivalence determination:
	IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance;
	IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility
	IEC 60601-2-22 Medical Electrical Equipment-Part 2-22:Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser Equipment
	IEC 60825-1 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
Results of Clinical Study:	A human clinical study was not required as the device is substantially equivalent to the predicate devices.

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510(K) Summary PicoLazer Multi-wavelength Laser

Technical Specification Comparison:

Characteristic	PicoLazer(K192583)		PicoWay LaserSystem (K170597)		PicoCare Family(K181272)
Wavelength (nm)	1064nm	532nm	1064nm	532nm	1064nm	532nm
Laser Type	Nd:YAG		Nd:YAG		Nd:YAG
Max Energy (mJ)	500mJ	250mJ	800mJ	300mJ	600mJ	300mJ
Peak Power	1.3GW	0.8GW	0.9GW	0.53GW	1.33GW	0.8GW
Spot Size	Max 10mm		Max 10mm		Max 10mm
Pulse Duration	450ps	375ps	450ps	375ps	450ps
Pulse Repetitionrate (Hz)	1~10Hz		1~10Hz		1~10Hz

Physical Specification:

aracteristic	PicoLazer(K192583)	PicoWay LaserSystem (K170597)	PicoCare Family(K181272)
Console Weight	176lbs	275lbs	198lbs
Console Size	25(W)x26(D)x48(H)in	18(W)x27(D)x42(H)in	18(W)x37(D)x36(H)in
Voltage, Current	100-120 VAC, 20 A200-240 VAC, 15 A	200-240 VAC, 30A	100-120 VAC, 20 A220-230 VAC, 15 A
Frequency	50/60Hz	50/60Hz	50/60Hz

Indication for Use Comparison:

	PicoLazer(K192583)	PicoWay Laser System(K170597)	PicoCare Family (K181272)
1064nm Laser	Treatment of benignpigmented lesions onpatients with Fitzpatrickskin types I-VI	Treatment of benign pigmentedlesions on patients withFitzpatrick skin types I-IV	Tattoo removal for darkcolored tattoo inks and formulticolored tattooscontaining dark coloredtattoo inks on patients with all
	Tattoo removal for darkcolored tattoo inks andfor multicolored tattooscontaining dark coloredtattoo inks on patientswith all skin types(Fitzpatrick I-VI)	Removal of tattoos for all skintypes (Fitzpatrick I-VI) to treat thefollowing colors: black, brown,green, blue, and purple.	skin types (Fitzpatrick I-VI)
532nm Laser	Treatment of benignpigmented lesions onpatients with Fitzpatrickskin types I-III	Treatment of benign pigmentedlesions on patients withFitzpatrick skin types I-IV	Tattoo removal for lightercolored tattoo inks, includingred and yellow inks, onpatients with Fitzpatrick skintypes I-III
	Tattoo removal forlighter colored tattooinks, including red andyellow inks, on patientswith Fitzpatrick skintypes I-III	Removal of tattoos for Fitzpatrickskin types I-III to treat thefollowing colors: red, yellow, andorange.

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510(K) Summary PicoLazer Multi-wavelength Laser

Conclusion:

The PicoLaser Laser System's intended use, indications for use and technical specifications are substantially equivalent to the PicoWay Laser System and the PicoCare Family of Lasers.

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.