(79 days)
Not Found
No
The document describes a laser hair removal system based on selective photothermolysis and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes.
The device is used for "Treatment of Pseudofolliculitis barbae (PFB)", which is a medical condition, thus making the device therapeutic.
No
The device is described as a hair removal system, which is a therapeutic rather than a diagnostic function. Its purpose is to treat conditions like hair regrowth and pseudofolliculitis barbae, not to diagnose them.
No
The device description clearly outlines a physical medical electrical equipment system consisting of a central unit and removable applicators that emit laser radiation. While software is mentioned in the standards compliance (IEC 62304), the core functionality and components are hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The PRIMELASE diode laser hair removal system is described as a medical electrical equipment intended for hair removal treatment and the treatment of Pseudofolliculitis barbae (PFB). It works by applying laser energy to the skin to target hair follicles.
- Lack of Specimen Examination: The device does not examine any specimens from the human body in vitro. It directly interacts with the patient's skin.
- Intended Use: The stated intended uses are therapeutic (hair removal and PFB treatment), not diagnostic or monitoring based on in vitro analysis of specimens.
Therefore, the PRIMELASE diode laser hair removal system falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
GEX
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
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 (Part 21 CFR 801 Subpart D)
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)
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:
-
- IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
- 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
-
- IEC 62304: Medical device software software life cycle processes
-
- 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
-
- I IEC 60601-1-6: Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
-
- IEC 60825 1: Safety of laser products Part 1: Equipment classification and requirements.
-
- ISO 14971: Medical devices Application of risk management to medical devices.
-
- I SO 10993-5: Biological Evaluation of Medical Device. Part 5-Tests for In Vitro cytotoxicity
-
- ISO 10993-10: Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization
No clinical study is included in this submission.
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). 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
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
Enclosure
2
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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3
TRADITIONAL 510(K)
PRIMELASE
005_510(K) Summary (21 CFR 868.5160)
5.1 Submitter Information:
| Application Correspondent: | Vardhini Kirthivas
Freyr Global Regulatory Solutions and Services
Level 4, Building No. H-08, Phoenix SEZ,
Phase 2, Gachibowli, Hyderabad,
Telangana, India, 500081 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | +91 - 9940445965 |
| Email: | vardhini.kirthivas@FreyrSolutions.com |
| Company: | High Technology Products, S.L.U.
Passatge Masoliver, 24 - 28
08005 Barcelona, Catalonia Spain |
| Phone: | +34 93 458 85 66 |
| Contact Person: | Mr. Sergi Lozano |
| Email: | sergi@cocoonmedical.com |
| Date Prepared: | April 25th, 2019 |
| Prepared By | Sravan Kumar Manchikanti
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
-
- The Modified Alma Lasers XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL Soprano XL and Soprano™] – K140009 by Alma Lasers Ltd.
-
- Lightsheer Desire; Lightsheer Desire Light; Lightsheer Duet; Lightsheer Infinity K170179 by Lumenis Ltd.
-
- InMode Diolaze System K180719 by InMode MD Ltd.
4
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). ●
5
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:
-
- IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
- 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
-
- IEC 62304: Medical device software software life cycle processes
-
- 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
-
- I IEC 60601-1-6: Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
-
- IEC 60825 1: Safety of laser products Part 1: Equipment classification and requirements.
-
- ISO 14971: Medical devices Application of risk management to medical devices.
-
- I SO 10993-5: Biological Evaluation of Medical Device. Part 5-Tests for In Vitro cytotoxicity
-
- 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.
6
TRADITIONAL 510(K)
PRIMELASE
5.8 Substantially Equivalence (SE) Comparison
Table 2: Comparison table
| S.
No. | Parameters for
Substantial Equivalence | Soprano ICE
(K140009) | Lightsheer Infinity
(K170179) | InMode Diolaze XL System
(K180719) | PRIMELASE |
|-----------|------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------|----------------------------------------|---------------------------------------------------|
| 1 | Company | Alma Lasers, Ltd, | Lumenis Ltd. | InMode MD Ltd. | High Technology Products
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
array | AlGaAs Laser diode
array | Diode Laser | AlGaAs Laser diode array |
| 5 | Laser Wavelength | 755 nm,
810 nm | 805 nm,
1060 nm | 810 nm
810/1064 nm
755/810 nm | 755 nm,
810 nm,
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
actually used (as per
treatment protocols) | 40 J/cm2 | 48 J/cm2 | 40 J/cm2 | 43 J/cm2 |
| 10 | Frequency | UP TO 3 Hz (HR)
5 - 10 Hz (SHR) | Up to 3 Hz | 1 – 2 Hz
5 Hz (Glide) | UP TO 3 Hz (static)
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,
thermo-electrical | Chilltip contact cooling | Skin contact cooling | Contact continuous,
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 &
Foot Control | Main unit and
Handpiece | Main unit, Handpiece &
Foot Control | Main unit, Handpiece &
Foot Control (Optional) |
| 18 | Laser Classification | Class IV | Class IV | Class IV | Class IV |
| 19 | Power Supply | 120VAC, 11A, 50/60 Hz,
single phase
220/230VAC, 6A, 50/60
Hz, single phase | 100-240 VAC +/-10%,
15 A max. 50/60 Hz. | 100 - 240 VAC
50/60 Hz, | Single phase, 100-240V
50-60 Hz |
| 20 | Dimension | 53 cm wide x 57 cm deep
x 120 cm high | 44 x 50 x 123 cm | 46cm W x 46cm D x 100cm
H | 1140 x 480 x 550 mm |
| 21 | Weight | 50 Kg (110 lbs) | 58 kg | 32 Kg | 75 Kg |
7
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.