(120 days)
Not Found
No
The summary describes a laser system with specific wavelengths and pulse durations for aesthetic and surgical applications. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies listed are focused on electrical and laser safety standards, not algorithmic performance.
Yes
The device is described as a laser system for "surgical and aesthetic applications" and its indications for use include "treatment of benign pigmented lesions" and "tattoo removal," which are therapeutic interventions. Additionally, the performance studies mention "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."
No
The "Intended Use / Indications for Use" section specifies the device is for "surgical and aesthetic applications" like "treatment of benign pigmented lesions" and "tattoo removal," which are therapeutic and aesthetic procedures, not diagnostic.
No
The device description explicitly lists hardware components such as a system console, articulated arm, laser handpiece, footswitch, and remote interlock plug, indicating it is a physical laser system, not software only.
Based on the provided information, the PicoLazer laser system is not an IVD (In Vitro Diagnostic) device.
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 treatment of patients.
- Device Description: The description details a laser system with a handpiece, articulated arm, etc., which are components of a device used for external procedures on the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. The PicoLazer is a therapeutic and aesthetic device that acts directly on the patient's skin.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
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)
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.
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.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.
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
1
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
2
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)
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
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, LLC |
| 105 Citation Court | |
| Birmingham, AL 35209 | |
| Contact Person: | Mr. Mark Rohrer |
| Telephone: | 205-356-1172 - phone |
| mrohrer@rohreraesthetics.com | |
| Preparation Date: | September 15, 2019 |
| Device Trade Name: | PicoLazer Laser System |
| Common Name: | Surgical Powered Lasers and Delivery Devices/Hand piece |
| Accessories | |
| Regulation Name: | Laser surgical instrument for use in general and |
| plastic 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 Candela |
| Corporation | |
| 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 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. |
4
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. |
5
510(K) Summary PicoLazer Multi-wavelength Laser
Technical Specification Comparison:
| Characteristic | PicoLazer
(K192583) | | PicoWay Laser
System (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 Repetition
rate (Hz) | 110Hz | | 110Hz | | 1~10Hz | |
Physical Specification:
| aracteristic | PicoLazer
(K192583) | PicoWay Laser
System (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 A
200-240 VAC, 15 A | 200-240 VAC, 30A | 100-120 VAC, 20 A
220-230 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 benign
pigmented lesions on
patients with Fitzpatrick
skin types I-VI | Treatment of benign pigmented
lesions on patients with
Fitzpatrick skin types I-IV | Tattoo removal for dark
colored tattoo inks and for
multicolored tattoos
containing dark colored
tattoo inks on patients with all |
| | | 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) | Removal of tattoos for all skin
types (Fitzpatrick I-VI) to treat the
following colors: black, brown,
green, blue, and purple. | skin types (Fitzpatrick I-VI) |
| 532nm Laser | | Treatment of benign
pigmented lesions on
patients with Fitzpatrick
skin types I-III | 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 |
| | | Tattoo removal for
lighter colored tattoo
inks, including red and
yellow inks, on patients
with Fitzpatrick skin
types I-III | Removal of tattoos for Fitzpatrick
skin types I-III to treat the
following colors: red, yellow, and
orange. | |
6
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.