Primelase Excellence

K191321 · High Technology Products S.L.U · GEX · Aug 2, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K191321
• Device Name: Primelase Excellence
• Applicant: High Technology Products S.L.U
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 2, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hair Removal with Static and Dynamic modes 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 regime. Treatment of Pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI).

Device Story

PRIMELASE is a diode laser hair removal system utilizing selective photothermolysis to destroy hair follicles via melanin absorption of infrared light (755-1060 nm). The system comprises a central unit and five removable applicators containing AlGaAs laser diode arrays. The device is operated by clinicians in a clinical setting. The applicator sapphire tip, cooled to 5°C, contacts the skin to provide epidermal protection and partial anesthesia. Treatment modes include 'Dynamic' (low fluence, high frequency) for initial treatments and 'Static' (high fluence, low frequency) for residual hair. Energy emission is triggered by a finger switch. The device provides permanent hair reduction and treats PFB, benefiting patients by reducing hair regrowth and associated skin conditions.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

AlGaAs laser diode array; 755-1060 nm wavelength; sapphire contact cooling (5°C); Class IV laser; LCD touch-screen interface; finger switch activation; single-phase power (100-240V, 50-60Hz). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, and ISO 10993-10.

Indications for Use

Indicated for permanent hair reduction and treatment of Pseudofolliculitis barbae (PFB) in patients of all skin types (Fitzpatrick I-VI).

Regulatory Classification

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.

Predicate Devices

• Soprano XL / Soprano (K140009)
• Lightsheer Desire; Lightsheer Desire Light; Lightsheer Duet; Lightsheer Infinity (K170179)
• InMode Diolaze System (K180719)

Submission Summary (Full Text)

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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 text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. The FDA logo is a recognizable symbol of the agency responsible for regulating food and drugs in the United States.

High Technology Products SLU % Vardhini Kirthivas Official Correspondent Freyr Global Regulatory Solutions and Services Level 4, Building No. H-08, Phoenix SEZ, Phase 2, Gachibowli, Hyderabad, 500081 In

August 2, 2019

# Re: K191321

Trade/Device Name: Primelase Excellence 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 25, 2019 Received: May 15, 2019

Dear Vardhini Kirthivas:

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

Enclosure

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# Indications for Use

510(k) Number (if known) K191321

#### Device Name

PRIMELASE Diode Laser Hair Removal System

Indications for Use (Describe)

Indications for use for PRIMELASE diode laser hair removal system with 755mm, 810mm and 810 - 1060mm applicators include:

· Hair Removal with Static and Dynamic modes 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 regime.

• Treatment of Pseudofolliculitis barbae (PFB).

· Use on all skin types (Fitzpatrick I-VI).

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# TRADITIONAL 510(K)

#### PRIMELASE

# 005_510(K) Summary (21 CFR 868.5160)

#### 5.1 Submitter Information:

| Application Correspondent: | Vardhini Kirthivas<br>Freyr Global Regulatory Solutions and Services<br>Level 4, Building No. H-08, Phoenix SEZ,<br>Phase 2, Gachibowli, Hyderabad,<br>Telangana, India, 500081 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | +91 - 9940445965 |
| Email: | [e-mail] |
| Company: | High Technology Products, S.L.U.<br>Passatge Masoliver, 24 - 28<br>08005 Barcelona, Catalonia Spain |
| Phone: | [phone] |
| Contact Person: | Mr. Sergi Lozano |
| Email: | [e-mail] |
| Date Prepared: | April 25th, 2019 |
| Prepared By | Sravan Kumar Manchikanti<br>Freyr Global Regulatory Solutions and Services |

#### 5.2 Device Identification

| Trade Name: | primelase excellence |
|----------------------|-------------------------------------------|
| Common Name: | PRIMELASE Diode Laser Hair Removal System |
| Classification Name: | Powered Laser Surgical Instrument |

#### Table 1: Device Identification

| Regulation No. | Product Code | Device Class |
|-----------------|--------------|--------------|
| 21 CFR 878.4810 | GEX | Class II |

## 5.3 Predicate Devices

- 1. The Modified Alma Lasers XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL Soprano XL and Soprano™] – K140009 by Alma Lasers Ltd.
- 2. Lightsheer Desire; Lightsheer Desire Light; Lightsheer Duet; Lightsheer Infinity K170179 by Lumenis Ltd.
- 3. InMode Diolaze System K180719 by InMode MD Ltd.

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# TRADITIONAL 510(K)

#### 5.4 Device Description

PRIMELASE diode laser hair removal system is a medical electrical equipment intended for hair removal treatment, the basic principle of which is selective photothermolysis, which consist in the specific destruction of a follicle due to an increase of the temperature induced by a high-powered beam of light which is selectively absorbed by the melanin.

The PRIMELASE machine consists of a central unit and a set of 5 removable applicators. The PRIMELASE equipment emits laser radiation (beam infrared light with a wavelength range of 755 mm to 1060 nm, typically and most used 810 nm.), pulsed through the laser aperture situated at the tip of the applicator.

The device applicator contains the diode which emits the laser energy whereas the power delivered, and the working frequency being controlled by the machine's central unit. The applicator emits the energy through a sapphire window, in contact with the skin throughout the treatment, aimed at damaging the hair follicle. The treatment can be provided in two modes, dynamic and static. Dynamic mode uses the low fluence & high frequency and is used for initial treatments. Static mode uses high fluence & low frequency and is used for residual hair removal.

The emission of energy is activated in the form of continuous pulses when pressing the applicator button. The applicator sapphire tip is cooled to a constant temperature to cool the skin, so that it partially anaesthetizes the tissue reducing the risk of damage to the epidermis during treatment

#### 5.5 Indications for Use

Indications for use for PRIMELASE diode laser hair removal system with 755nm, 810nm and 810 -1060nm applicators include:

- Hair Removal with Static and Dynamic modes 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 regime.
- Treatment of Pseudofolliculitis barbae (PFB). ●
- Use on all skin types (Fitzpatrick I-VI). ●

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# TRADITIONAL 510(K)

### 5.6 Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- 1. IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- 2. IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- 3. IEC 62304: Medical device software software life cycle processes
- 4. IEC 60601-2-22: Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- 5. I IEC 60601-1-6: Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- 6. IEC 60825 1: Safety of laser products Part 1: Equipment classification and requirements.
- 7. ISO 14971: Medical devices Application of risk management to medical devices.
- 8. I SO 10993-5: Biological Evaluation of Medical Device. Part 5-Tests for In Vitro cytotoxicity
- 9. ISO 10993-10: Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization

#### 5.7 Clinical Test Conclusion

No clinical study is included in this submission.

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# TRADITIONAL 510(K)

# PRIMELASE

# 5.8 Substantially Equivalence (SE) Comparison

# Table 2: Comparison table

| S.<br>No. | Parameters for<br>Substantial Equivalence | Soprano ICE<br>(K140009) | Lightsheer Infinity<br>(K170179) | InMode Diolaze XL System<br>(K180719) | PRIMELASE |
|-----------|------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------|----------------------------------------|---------------------------------------------------|
| 1 | Company | Alma Lasers, Ltd, | Lumenis Ltd. | InMode MD Ltd. | High Technology Products<br>SLU |
| 2 | Product Code | GEX | GEX | GEX | GEX |
| 3 | Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| 4 | Principle of Operation | AlGaAs Laser diode<br>array | AlGaAs Laser diode<br>array | Diode Laser | AlGaAs Laser diode array |
| 5 | Laser Wavelength | 755 nm,<br>810 nm | 805 nm,<br>1060 nm | 810 nm<br>810/1064 nm<br>755/810 nm | 755 nm,<br>810 nm,<br>810 - 1060 nm |
| 6 | Laser Contact | Sapphire window | Pure sapphire, AL2O3 | Sapphire output window | Pure sapphire, AL2O3 |
| 7 | Spot Sizes (CMxCM) | 12x10, 15x10, 20x10 | 9x9, 27x9, 22x35 | 11x 27.5 | 20x9, 30x9, 30x17 |
| 8 | Fluence (Energy Density) | 120J/cm2 | 100 J/cm2 | 5-40 J/cm2 | 80 J/cm2 |
| 9 | Maximum Fluence<br>actually used (as per<br>treatment protocols) | 40 J/cm2 | 48 J/cm2 | 40 J/cm2 | 43 J/cm2 |
| 10 | Frequency | UP TO 3 Hz (HR)<br>5 - 10 Hz (SHR) | Up to 3 Hz | 1 – 2 Hz<br>5 Hz (Glide) | UP TO 3 Hz (static)<br>5 - 10 Hz (dynamic) |
| 11 | Pulse Duration | 3.3 - 200 ms | 5 - 400 ms | 5-200 ms | 3 - 400 ms/ AUTO (3 ms) |
| 12 | Treatment Mode | SHR, HR & LB | Repetitive impulses | Single, Continuous and Glide | Static & Dynamic |
| 13 | Tissue Cooling | Contact continuous,<br>thermo-electrical | Chilltip contact cooling | Skin contact cooling | Contact continuous,<br>thermo-electrical |
| 14 | Cooling temperature | 4°C (39°F) | 2°C - 12°C | 7 - 12° C | 5°C |
| 15 | User Interface | LCD touch-screen | LCD touch-screen | LCD touch-screen | LCD touch-screen |
| 16 | Pulsing Control | Finger switch | Finger switch | Finger switch | Finger switch |
| 17 | Configuration | Main unit, Handpiece &<br>Foot Control | Main unit and<br>Handpiece | Main unit, Handpiece &<br>Foot Control | Main unit, Handpiece &<br>Foot Control (Optional) |
| 18 | Laser Classification | Class IV | Class IV | Class IV | Class IV |
| 19 | Power Supply | 120VAC, 11A, 50/60 Hz,<br>single phase<br>220/230VAC, 6A, 50/60<br>Hz, single phase | 100-240 VAC +/-10%,<br>15 A max. 50/60 Hz. | 100 - 240 VAC<br>50/60 Hz, | Single phase, 100-240V<br>50-60 Hz |
| 20 | Dimension | 53 cm wide x 57 cm deep<br>x 120 cm high | 44 x 50 x 123 cm | 46cm W x 46cm D x 100cm<br>H | 1140 x 480 x 550 mm |
| 21 | Weight | 50 Kg (110 lbs) | 58 kg | 32 Kg | 75 Kg |

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# TRADITIONAL 510(K)

### PRIMELASE

### 5.9 Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.