(69 days)
No
The summary describes a microprocessor-controlled laser system with different wavelengths and modes for hair removal. It mentions software validation but does not include any terms or descriptions indicative of AI or ML capabilities, such as image processing, learning algorithms, or performance metrics typically associated with AI/ML models.
Yes
The device is intended for "permanent reduction in hair regrowth" and "treatment of Pseudo folliculitis Barbae (PFB)", which are therapeutic uses. Additionally, the performance studies section refers to "surgical, cosmetic, therapeutic and diagnostic laser Equipment," indicating its therapeutic classification.
No
Explanation: The device is intended for dermatologic and general surgical procedures, specifically permanent reduction in hair regrowth and treatment of Pseudo folliculitis Barbae. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a "Multi-wavelength Laser" system consisting of hardware components like a console, handpieces, and a footswitch, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatologic and general surgical procedures" and specifically for "permanent reduction in hair regrowth" and "treatment of Pseudo folliculitis Barbae (PFB)". These are therapeutic and cosmetic applications performed directly on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests.
- Device Description: The description details a laser system that delivers energy to the target area on the body. This is consistent with a therapeutic/surgical device, not an IVD.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, diagnostic purposes, or any of the typical components or processes associated with IVD devices.
Therefore, the EpiLaze Multi-wavelength Laser is a therapeutic/surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EpiLaze Multi-wavelength Laser is intended for use in dermatologic and general surgical procedures.
Indication for Use for the 1064nm wavelength:
- The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) Modes are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen: and
- treatment of Pseudo folliculitis Barbae (PFB).
Indication for Use for the 810nm wavelength:
- The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) . Modes are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Indication for use for the 755nm wavelength:
- The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) Modes are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
The STANDARD mode can be used on all skin types (Fitzpatrick I-VI), including tanned skin. The SFT mode can only be used on Fitzpatrick skin type I-IV. Do not use the SFT mode on tanned skin.
Product codes
GEX
Device Description
The EpiLaze Multi-wavelength Laser is a microprocessor-controlled, user friendly 755nm, 810nm and 1064nm Diode laser system using a sealed diode pack that produces a maximum energy of 120J/cm². The system incorporates a diode pack within each hand piece, and the energy is delivered from the hand piece directly to the desired target. The EpiLaze Multi-wavelength Laser consists of a console, a touch screen user interface, a footswitch and 2 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
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 Data: The following performance data was provided in support of the substantial equivalence determination:
- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance;
- IEC 60601-1-2:2014 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;
- Bench testing to show that the difference between the set and delivered energy parameters of the device falls within specifications.
- Software verification and validation testing was performed per FDA's quidance, General Principles of Software Validation; Final Guidance for Industry and FDA Staff, dated January 11, 2002.
- Biocompatibility testing was not needed as the relevant parts are identical in the subject device and reference predicate.
Results of Clinical Study:
A human clinical study was not required as the device is identical to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized depiction of a human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Rohrer Aesthetics, LLC Mark Rohrer President 105 Citation Court Homewood, Alabama 35209
July 9, 2019
Re: K191162
Trade/Device Name: EpiLaze Multi-wavelength Laser 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: April 24, 2019 Received: May 1, 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 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
1
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.
Neil R.P. Ogden Assistant Director, THT4A4 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
2
Indications for Use
510(k) Number (if known) K191162
Device Name EpiLaze Multi-wavelength Laser
Indications for Use (Describe)
Intended Use:
The EpiLaze Multi-wavelength Laser is intended for use in dermatologic and general surgical procedures.
Indication for Use for the 1064nm wavelength:
-
The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) Modes are intended for
-
permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen: and
-
treatment of Pseudo folliculitis Barbae (PFB).
Indication for Use for the 810nm wavelength:
-
The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) . Modes are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Indication for use for the 755nm wavelength: -
The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) ● Modes are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
The STANDARD mode can be used on all skin types (Fitzpatrick I-VI), including tanned skin. The SFT mode can only be used on Fitzpatrick skin type I-IV. Do not use the SFT mode on tanned skin.
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.
3
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."
4
This 510(K) Summary of safety and effectiveness for the EpiLaze Multi-wavelength Laser is submitted in accordance with the requirements of 21 CFR 807.92.
| Applicant: | Rohrer Aesthetics, LLC |
|---|---|
| Address: | Rohrer Aesthetics, LLC |
| 105 Citation Court | |
| Homewood, AL 35209 | |
| Contact Person: | Mr. Mark Rohrer |
| Telephone: | 205-356-1172 - phone |
| mrohrer@rohreraesthetics.com | |
| Preparation Date: | July 5, 2019 |
| Device Trade Name: | EpiLaze Multi-wavelength Laser |
| 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) |
| Primary Predicate Device: | Modified Alma Lasers Soprano XL Family of Multi- |
| application & Multi-technology Platform, Soprano Yag Hand | |
| Piece (Soprano Ice, K170626) | |
| Reference Predicate Device: | Multilaser System (K123777) |
| Regulatory Class: | Class II Prescription Use |
| Description of the EpiLaze Multi- | |
| wavelength Laser: | The EpiLaze Multi-wavelength Laser is a microprocessor- |
| controlled, user friendly 755nm, 810nm and 1064nm Diode | |
| laser system using a sealed diode pack that produces a | |
| maximum energy of 120J/cm². | |
| The system incorporates a diode pack within each hand | |
| piece, and the energy is delivered from the hand piece | |
| directly to the desired target. | |
| The EpiLaze Multi-wavelength Laser consists of a console, a | |
| touch screen user interface, a footswitch and 2 handpieces | |
| Intended use of the Epilaze Multi- | |
| wavelength Laser: | Intended Use: |
| The EpiLaze Multi-wavelength Laser is intended for use in | |
| dermatologic and general surgical procedures. | |
| Indication for Use for the 1064nm wavelength: | |
| • The Standard Hair Removal (STANDARD) and Smooth |
5
Flow Technology Hair Removal (SFT) Modes are intended for
- permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs regrowing when measured at 6.9 and 12 months after the completion of a treatment regimen, and
- treatment of Pseudo folliculitis Barbae (PFB).
Indication for Use for the 810nm wavelength: · The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) Modes are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Indication for use for the 755nm wavelength: · The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) Modes are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
The STANDARD mode can be used on all skin types (Fitzpatrick I-VI), including tanned skin. The SFT mode can only be used on Fitzpatrick skin type I-IV. Do not use the SFT mode on tanned skin.
Performance Data: The following performance data was provided in support of the substantial equivalence determination:
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance;
IEC 60601-1-2:2014 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;
Bench testing to show that the difference between the set and delivered energy parameters of the device falls within specifications.
Software verification and validation testing was performed per FDA's quidance, General Principles of Software Validation; Final Guidance for Industry and FDA Staff, dated January 11, 2002.
Biocompatibility testing was not needed as the relevant parts
6
are identical in the subject device and reference predicate.
Results of Clinical Study:
A human clinical study was not required as the device is identical to the predicate device.
Technical Specifications Comparison:
1064nm
| Characteristic | EpiLaze (510K Pending) | Soprano Ice (K170626) | ||
|---|---|---|---|---|
| Wavelength (nm) | 1064 | 1064 | ||
| Laser Media | Solid State | Solid State | ||
| Mode | STANDARD | SFT | HR | SHR |
| Spot Size | 10mm x 10mm with optional tapered tip 6mm | 10mm x 10mm with optional tapered tip 6mm | ||
| Pulse width (msec) | 3.3-280 | 3.3-280 | ||
| Pulse Repetition rate (Hz) | 0.5-3 | 5-10 | 0.5-3 | 5-10 |
| Energy Density (Fluence, J/cm²) | 2-120 | 2-20 | 2-120 | 2-20 |
| Delivery Devices | Nonsterile, Reusable, cleanable | Nonsterile, Reusable, cleanable |
7
| Characteristic | EpiLaze (510K Pending) | Soprano Ice (K170626/140009) |
|---|---|---|
| Wavelength (nm) | 810, 755 | 810, 755 |
| Laser Media | Solid State | Solid State |
| Mode | STANDARD SFT | HR SHR LB |
| Spot Size | 810nm | |
| 12mm x 10mm | ||
| 20mm x 10mm | ||
| Optional tapered tips: 6mm and 12mm |
755nm
15mm x 10mm | 810nm
12mm x 10mm
20mm x 10mm
Optional tapered tips: 6mm and 12mm
755nm
15mm x 10mm |
| Pulse width (msec) | 3.3-200 | 3.3-200 |
| Pulse Repetition rate (Hz) | 0.5-3 5-10 | 0.5-3 5-10 2 |
| Energy Density (Fluence, J/cm²) | 2 - 120 2-20 | 2-120 2-20 755nm Up to 25,
810nm Up 40 |
| Delivery Devices | Nonsterile, Reusable, cleanable | Nonsterile, Reusable, cleanable |
Technical Specifications Comparison:
The technical specifications of the subject and predicate devices for 1064 nm wavelength are identical.
The technical specifications of the subject and predicate devices for 810 and 755 nm wavelengths are identical for comparable modes. The subject device does not have LB mode and related indications for use, as in the predicate.
Indication for Use Comparison:
| | EpiLaze (510K
Pending) | Soprano Ice
(K170626) | Comparison |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1064nm
Laser | The Standard Hair Removal
(STANDARD) and Smooth
Flow
Technology Hair
Removal (SFT) Modes are
intended for
- Permanent
reduction in hair
regrowth defined as
a long term, stable
reduction in the
number of hairs re- | The Hair Removal (HR)
and Super Hair Removal
(SHR) Mode are intended
for permanent reduction
in hair regrowth defined
as a long term, stable
reduction in the number of
hairs re-growing when
measured at 6,9 and 12
months after the
completion of a treatment
regimen. | Identical |
| | EpiLaze (510K
Pending) | Soprano Ice
(K170626) | Comparison |
| | growing when
measured at 6,9
and 12 months after
the completion of a
treatment regimen,
and - Treatment of
Pseudo folliculitis
Barbae (PFB).
The STANDARD mode can
be used on all skin types
(Fitzpatrick I-VI), including
tanned skin. The SFT mode
can only be used on
Fitzpatrick skin type I-IV. Do
not use the SFT mode on
tanned skin. | Treatment of Pseudo
folliculitis Barbae (PFB)
Use on all skin types
(Fitzpatrick I-VI), including
tanned skin. | |
| 810nm
Laser | The Standard Hair Removal
(STANDARD) and Smooth
Flow Technology Hair
Removal (SFT) Modes are
intended for permanent
reduction in hair regrowth
defined as a long term,
stable reduction in the
number of hairs re-growing
when measured at 6,9 and
12 months after the
completion of a treatment
regimen.
The STANDARD mode can
be used on all skin types
(Fitzpatrick I-VI), including
tanned skin. The SFT mode
can only be used on
Fitzpatrick skin type I-IV. Do
not use the SFT mode on
tanned skin. | The Hair Removal (HR)
and Super Hair Removal
(SHR) Mode are intended
for permanent reduction in
hair regrowth defined as a
long term, stable
reduction in the number of
hairs re-growing when
measured at 6,9 and 12
months after the
completion of a treatment
regimen.
The treatment of benign
vascular and pigmented
lesions in LB mode.
Use on all skin types
(Fitzpatrick I-VI), including
tanned skin | Different
The Epilaze cannot
treat benign
vascular lesions or
pigmented lesions
since it does not
have LB mode, as
in the predicate. |
| | EpiLaze (510K
Pending) | Soprano Ice
(K170626) | Comparison |
| 755nm
Laser | The Standard Hair Removal
(STANDARD) and Smooth
Flow Technology Hair
Removal (SFT) Modes are
intended for permanent
reduction in hair regrowth
defined as a long term,
stable reduction in the
number of hairs re-growing
when measured at 6,9 and
12 months after
the
completion of a treatment
regimen.
The STANDARD mode can
be used on all skin types
(Fitzpatrick I-VI), including
tanned skin. The SFT mode
can only be used on
Fitzpatrick skin type I-IV. Do
not use the SFT mode on
tanned skin. | The Hair Removal (HR)
and Super Hair Removal
(SHR) Mode are intended
for permanent reduction in
hair regrowth defined as a
long term, stable
reduction in the number of
hairs re-growing when
measured at 6,9 and 12
months after the
completion of a treatment
regimen.
The treatment of benign
vascular and pigmented
lesions in LB mode.
Use on all skin types
(Fitzpatrick I-VI), including
tanned skin | Different
The Epilaze cannot
treat benign
vascular lesions or
pigmented lesions
since it does not
have LB mode, as
in the predicate. |
8
9
Conclusion: The subject device EpiLaze Multi-wavelength Laser is substantially equivalent to the primary predicate device Modified Alma Lasers Soprano XL Family of Multi-application & Multitechnology Platform, Soprano Yag Hand Piece (Soprano Ice, K170626) for comparable indications for use.