(69 days)
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.
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
The provided text describes the EpiLaze Multi-wavelength Laser, a device intended for dermatologic and general surgical procedures, specifically for permanent hair reduction and treatment of Pseudo folliculitis Barbae (PFB).
The device did not undergo a clinical study to prove its performance against acceptance criteria. Instead, its substantial equivalence to a predicate device (Modified Alma Lasers Soprano XL Family of Multi-application & Multi-technology Platform, Soprano Yag Hand Piece, K170626, referred to as Soprano Ice) was established through a comparison of technical specifications and regulatory compliance.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since no specific acceptance criteria for a clinical study or device performance metrics like sensitivity/specificity are reported, the table below reflects the comparison against the predicate device, which forms the basis of "performance" in this 510(k) submission.
| Characteristic | Acceptance Criteria (Predicate Device K170626 performance, where applicable) | EpiLaze Multi-wavelength Laser (Reported Performance) |
|---|---|---|
| 1064nm Wavelength | ||
| Wavelength (nm) | 1064 | 1064 |
| Laser Media | Solid State | Solid State |
| Mode | HR (STANDARD equivalent), SHR (SFT equivalent) | STANDARD, SFT |
| 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 (HR), 5-10 (SHR) | 0.5-3 (STANDARD), 5-10 (SFT) |
| Energy Density (J/cm²) | 2-120 (HR), 2-20 (SHR) | 2-120 (STANDARD), 2-20 (SFT) |
| Delivery Devices | Nonsterile, Reusable, cleanable | Nonsterile, Reusable, cleanable |
| 810nm & 755nm Wavelengths | ||
| Wavelength (nm) | 810, 755 | 810, 755 |
| Laser Media | Solid State | Solid State |
| Mode | HR (STANDARD equivalent), SHR (SFT equivalent), LB | STANDARD, SFT |
| Spot Size | 810nm: 12mm x 10mm, 20mm x 10mm, optional 6mm & 12mm tapered tips; 755nm: 15mm x 10mm | 810nm: 12mm x 10mm, 20mm x 10mm, optional 6mm & 12mm tapered tips; 755nm: 15mm x 10mm |
| Pulse width (msec) | 3.3-200 | 3.3-200 |
| Pulse Repetition Rate (Hz) | 0.5-3 (HR), 5-10 (SHR), 2 (LB) | 0.5-3 (STANDARD), 5-10 (SFT) |
| Energy Density (J/cm²) | 2-120 (HR), 2-20 (SHR), 755nm Up to 25 (LB), 810nm Up to 40 (LB) | 2-120 (STANDARD), 2-20 (SFT) |
| Delivery Devices | Nonsterile, Reusable, cleanable | Nonsterile, Reusable, cleanable |
| Indications for Use (1064nm) | Permanent hair reduction; Treatment of PFB; Use on all skin types (Fitzpatrick I-VI), including tanned skin | Permanent hair reduction; Treatment of PFB; Use on all skin types (Fitzpatrick I-VI), including tanned skin for STANDARD mode; Fitzpatrick I-IV for SFT mode, not on tanned skin |
| Indications for Use (810nm & 755nm) | Permanent hair reduction; Treatment of benign vascular and pigmented lesions (LB mode); Use on all skin types (Fitzpatrick I-VI), including tanned skin | Permanent hair reduction; Use on all skin types (Fitzpatrick I-VI), including tanned skin for STANDARD mode; Fitzpatrick I-IV for SFT mode, not on tanned skin |
Conclusion from comparison: The technical specifications for the 1064nm wavelength are identical between the EpiLaze and the predicate. For 810nm and 755nm, the specifications are identical for comparable modes (STANDARD/SFT vs HR/SHR). The EpiLaze does not have the "LB mode" present in the predicate and thus does not include indications for treating benign vascular or pigmented lesions. This difference in indications for use is noted but does not prevent substantial equivalence for the shared indications.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The submission states, "A human clinical study was not required as the device is identical to the predicate device." Therefore, there was no independent test set of patients or data for the EpiLaze device's clinical performance.
- Data Provenance: Not applicable for clinical performance. The data provided focuses on technical specifications and regulatory compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable, as no human clinical study or test set requiring expert ground truth was conducted for this device's 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable, as no human clinical study or test set was conducted for this device's 510(k) submission.
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. This device is a laser system for hair removal/dermatological procedures, not an AI-assisted diagnostic or imaging interpretation device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser system, not an algorithm. Bench testing was performed to show the difference between set and delivered energy parameters, and software verification and validation were conducted. These are not "standalone algorithm performance" in the context of an AI device.
7. The Type of Ground Truth Used
- For Technical Specifications: The "ground truth" for the EpiLaze's technical specifications was established through internal testing by the manufacturer (Rohrer Aesthetics, LLC) to ensure the device met its design specifications and could be compared to the predicate device's published specifications.
- For Clinical Efficacy/Safety: The "ground truth" is implied to be established by the predicate device's existing clearance (K170626), which presumably had sufficient clinical data or a strong scientific basis to support its indications for use. The EpiLaze's claim of "substantial equivalence" means it is considered to achieve the same clinical effects for comparable indications without new clinical data.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device requiring a training set or ground truth establishment for a training set.
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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
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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
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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.
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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, LLC105 Citation CourtHomewood, AL 35209 |
| Contact Person: | Mr. Mark Rohrer |
| Telephone: | 205-356-1172 - phonemrohrer@rohreraesthetics.com |
| Preparation Date: | July 5, 2019 |
| Device Trade Name: | EpiLaze Multi-wavelength Laser |
| 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) |
| Primary Predicate Device: | Modified Alma Lasers Soprano XL Family of Multi-application & Multi-technology Platform, Soprano Yag HandPiece (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 Diodelaser system using a sealed diode pack that produces amaximum energy of 120J/cm². |
| The system incorporates a diode pack within each handpiece, and the energy is delivered from the hand piecedirectly to the desired target. | |
| The EpiLaze Multi-wavelength Laser consists of a console, atouch 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 indermatologic and general surgical procedures. |
| Indication for Use for the 1064nm wavelength:• The Standard Hair Removal (STANDARD) and Smooth |
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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
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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 |
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| 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 | 810nm12mm x 10mm20mm x 10mmOptional tapered tips: 6mm and 12mm755nm15mm x 10mm | 810nm12mm x 10mm20mm x 10mmOptional tapered tips: 6mm and 12mm755nm15mm 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 (510KPending) | Soprano Ice(K170626) | Comparison | |
|---|---|---|---|
| 1064nmLaser | The Standard Hair Removal(STANDARD) and SmoothFlowTechnology HairRemoval (SFT) Modes areintended for- Permanentreduction in hairregrowth defined asa long term, stablereduction in thenumber of hairs re- | The Hair Removal (HR)and Super Hair Removal(SHR) Mode are intendedfor permanent reductionin hair regrowth definedas a long term, stablereduction in the number ofhairs re-growing whenmeasured at 6,9 and 12months after thecompletion of a treatmentregimen. | Identical |
| EpiLaze (510KPending) | Soprano Ice(K170626) | Comparison | |
| growing whenmeasured at 6,9and 12 months afterthe completion of atreatment regimen,and- Treatment ofPseudo folliculitisBarbae (PFB).The STANDARD mode canbe used on all skin types(Fitzpatrick I-VI), includingtanned skin. The SFT modecan only be used onFitzpatrick skin type I-IV. Donot use the SFT mode ontanned skin. | Treatment of Pseudofolliculitis Barbae (PFB)Use on all skin types(Fitzpatrick I-VI), includingtanned skin. | ||
| 810nmLaser | The Standard Hair Removal(STANDARD) and SmoothFlow Technology HairRemoval (SFT) Modes areintended for permanentreduction in hair regrowthdefined as a long term,stable reduction in thenumber of hairs re-growingwhen measured at 6,9 and12 months after thecompletion of a treatmentregimen.The STANDARD mode canbe used on all skin types(Fitzpatrick I-VI), includingtanned skin. The SFT modecan only be used onFitzpatrick skin type I-IV. Donot use the SFT mode ontanned skin. | The Hair Removal (HR)and Super Hair Removal(SHR) Mode are intendedfor permanent reduction inhair regrowth defined as along term, stablereduction in the number ofhairs re-growing whenmeasured at 6,9 and 12months after thecompletion of a treatmentregimen.The treatment of benignvascular and pigmentedlesions in LB mode.Use on all skin types(Fitzpatrick I-VI), includingtanned skin | DifferentThe Epilaze cannottreat benignvascular lesions orpigmented lesionssince it does nothave LB mode, asin the predicate. |
| EpiLaze (510KPending) | Soprano Ice(K170626) | Comparison | |
| 755nmLaser | The Standard Hair Removal(STANDARD) and SmoothFlow Technology HairRemoval (SFT) Modes areintended for permanentreduction in hair regrowthdefined as a long term,stable reduction in thenumber of hairs re-growingwhen measured at 6,9 and12 months afterthecompletion of a treatmentregimen.The STANDARD mode canbe used on all skin types(Fitzpatrick I-VI), includingtanned skin. The SFT modecan only be used onFitzpatrick skin type I-IV. Donot use the SFT mode ontanned skin. | The Hair Removal (HR)and Super Hair Removal(SHR) Mode are intendedfor permanent reduction inhair regrowth defined as along term, stablereduction in the number ofhairs re-growing whenmeasured at 6,9 and 12months after thecompletion of a treatmentregimen.The treatment of benignvascular and pigmentedlesions in LB mode.Use on all skin types(Fitzpatrick I-VI), includingtanned skin | DifferentThe Epilaze cannottreat benignvascular lesions orpigmented lesionssince it does nothave LB mode, asin the predicate. |
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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.
§ 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.