(188 days)
Not Found
No
The provided text describes a diode laser device for dermatological procedures and does not mention any AI or ML components or functionalities.
Yes
The device is described as a laser system intended for medical treatments such as hair removal, pseudofolliculitis barbae, benign pigmented lesions, benign vascular lesions, and wrinkles. These are all conditions that fall under the scope of therapeutic indications.
No
The device is described as a laser for dermatologic and general surgical procedures, primarily for hair removal and treatment of various skin lesions, not for diagnosing conditions.
No
The device description explicitly states it is a "diode laser device which consists of a central unit and external applicators" and describes the physical components and their functions, indicating it is a hardware device.
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 used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- PRIMELASE Excellence Function: The description clearly states that PRIMELASE Excellence is a diode laser device that emits laser radiation to treat various dermatological conditions like hair removal, pseudofolliculitis barbae, benign pigmented lesions, benign vascular lesions, and wrinkles. It directly interacts with the patient's body using light energy.
- Lack of Sample Analysis: There is no mention of this device analyzing any biological samples taken from a patient. Its function is based on applying energy to the skin.
Therefore, PRIMELASE Excellence falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: PRIMELASE Excellence is intended for use in dermatologic and general surgical procedures.
Indications for Use:
PRIMELASE Excellence System with 810nm Laser applicator is intended for:
· 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).
- · Treatment of benign pigmented lesions
PRIMELASE Excellence System with 755nm Laser applicator is intended for:
· 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).
- · Treatment of benign pigmented lesions
PRIMELASE Excellence System with 1060nm Laser applicator is intended for:
· 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).
· Treatment of benign vascular lesions, including angiomas, telangiectasia, and other benign vascular lesions and leg veins. - Treatment of wrinkles
PRIMELASE Excellence System with 810-1060nm Laser applicator is intended for:
· 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 Excellence is a diode laser device which consists of a central unit and external applicators.
The PRIMELASE equipment emits laser radiation (beam infrared light with a wavelength range of 755 nm 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 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
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)
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 contains 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
December 17, 2020
High Technology Products SLU % Vardhini Kirthivas Vice President - Regulatory Services Freyr Global Regulatory Solutions & Services Level 4 Building No. H-08 Phoenix SEZ Phase 2 Gachibowli, Hyderabad, Telangana 500081 India
Re: K201594
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: June 8, 2020 Received: June 12, 2020
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.
1
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 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 medical devices and radiation-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.
Purva Pandya 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
2
Indications for Use
510(k) Number (if known) K201594
Device Name Primelase Excellence
Indications for Use (Describe) Intended Use: PRIMELASE Excellence is intended for use in dermatologic and general surgical procedures.
Indications for Use:
PRIMELASE Excellence System with 810nm Laser applicator is intended for:
· 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).
- · Treatment of benign pigmented lesions
PRIMELASE Excellence System with 755nm Laser applicator is intended for:
· 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).
- · Treatment of benign pigmented lesions
PRIMELASE Excellence System with 1060nm Laser applicator is intended for:
· 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).
· Treatment of benign vascular lesions, including angiomas, telangiectasia, and other benign vascular lesions and leg veins.
- Treatment of wrinkles
PRIMELASE Excellence System with 810-1060nm Laser applicator is intended for:
· 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
High Technology Products SLU, Spain
Traditional 510(k) Primelase Excellence
5. 510(k) Summary
| 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 |
| E-mail: | vardhini.kirthivas@FreyrSolutions.com |
| Legal Manufacturer: | 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 |
| E-mail: | slozano@cocoonmedical.com |
| Date Prepared: | 14 December 2020 |
5.2. Device Identification:
| Device Trade Name: | Primelase Excellence |
|---|---|
| Device Common Name: | PRIMELASE Excellence System |
| Classification Name: | Powered Laser Surgical Instrument |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |
5.3. Predicate Devices:
| Device Name | 510(k) Number |
|---|---|
| Primelase Excellence | K191321 |
| The Modified Alma Lasers XL TM Family | |
| of Multi-Application and Multi- | |
| Technology Platforms [SopranoXL | |
| SopranoXL and SopranoICE] | K172193 |
5
| Device Name | 510(k) Number |
|---|---|
| Lightsheer Desire; Lightsheer Desire | |
| Light; Lightsheer Duet; Lightsheer | |
| Infinity | K170179 |
5.4. Device Description
PRIMELASE Excellence is a diode laser device which consists of a central unit and external applicators.
The PRIMELASE equipment emits laser radiation (beam infrared light with a wavelength range of 755 nm 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 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.
Intended Use & Indications for Use 5.5.
Intended Use
PRIMELASE Excellence is intended for use in dermatologic and general surgical procedures.
Indications for Use
PRIMELASE Excellence System with 810nm Laser applicator is intended for:
- 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). ●
- . Treatment of benign pigmented lesions
PRIMELASE Excellence System with 755nm Laser applicator is intended for:
- 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.
6
- Treatment of Pseudofolliculitis barbae (PFB).
- o Use on all skin types (Fitzpatrick I-VI).
- Treatment of benign pigmented lesions o
PRIMELASE Excellence System with 1060nm Laser applicator is intended for:
- 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). ●
- Treatment of benign vascular lesions, including angiomas, hemangiomas, ● telangiectasia, and other benign vascular lesions and leg veins.
- Treatment of wrinkles .
PRIMELASE Excellence System with 810-1060mm Laser applicator is intended for:
- 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). 0
- Use on all skin types (Fitzpatrick I-VI). ●
5.6. Comparison of Technological Characteristics
The fundamental scientific technology, materials of construction and mechanism of operation are identical between the subject PRIMELASE equipment and the predicate devices. Table 2 summarizes the comparison of technological characteristics between the subject and predicate devices.
| S.No | Parameters | Soprano ICE
(K172193) | Lightsheer
Infinity
(K170179) | Primelase
Excellence
(K191321) | Primelase
Excellence
(Subject
device) |
|------|----------------------|--------------------------|-------------------------------------|------------------------------------------|------------------------------------------------|
| 1. | Manufacturer | Alma Lasers,
Ltd, | Lumenis Ltd | High
Technology
Products
S.L.U. | High
Technology
Products,
S.L.U. |
| 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 |
| Table 2 - Substantial Equivalence Table | ||
|---|---|---|
7
High Technology Products SLU, Spain
| S.No | Parameters | Soprano ICE
(K172193) | Lightsheer
Infinity
(K170179) | Primelase
Excellence
(K191321) | Primelase
Excellence
(Subject
device) |
|------|---------------------------|------------------------------------------------------------------------|-------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|
| 4. | Principle of
Operation | AlGaAs
Laser diode
array | AlGaAs
Laser diode
array | AlGaAs Laser
diode
array | AlGaAs Laser
diode
array |
| 5. | Laser
Classification | Class IV | Class IV | Class IV | Class IV |
| 6. | User
Interface | LCD touch
screen | LCD touch
screen | LCD touch
screen | LCD touch
screen |
| 7. | Pulsing
Control | Finger switch | Finger switch | Finger switch | Finger switch |
| 8. | Configuration | Main unit,
Handpiece
and Foot
control | Main unit
and
Handpiece | Main unit,
Handpiece
and Foot
control
(optional) | Main unit,
Handpiece
and Foot
control
(optional) |
| 9. | Laser
Wavelength | 755 nm
810 nm
1064nm | 805 nm
1060 nm | 755nm
810nm
810-1060nm | 755nm
810nm
1060nm
810-1060nm |
| 10. | Spot Size
(CM × CM) | 12x10,
15x10,
20x10,
10x10 | 9x9, 27x9,
22x35 | 20x9, 30x9,
30x17 | 20x9, 30x9,
30x17
10x10 |
| 11. | Laser Contact | Sapphire
window | Pure
sapphire,
A1203 | Pure sapphire,
A12O3 | Pure sapphire,
A1203 |
| 12. | Frequency | Up to 3Hz
(HR)
5 - 10Hz
(SHR) | Up to 3Hz | Up to 3Hz
(static)
5 — 10Hz
(dynamic) | Up to 3Hz
(static)
5 — 10Hz
(dynamic) |
| 13. | Pulse
duration | 3.3-200ms | 5-400ms | 3-400ms | 3-400ms |
| 14. | Fluence | 120J/cm² | 100J/cm² | 80J/cm² | 120J/cm² |
| 15. | Tissue
cooling | Contact
continuous,
Thermo-
electrical | Chilltip
contact
cooling | Contact
continuous,
Thermo-
electrical | Contact
continuous,
Thermo-
electrical |
| 16. | Cooling
Temperature | 4 °C | 2 °C -12 °C | 5 °C | 5 °C |
| 17. | Power supply | 120VAC,
11A, 50/60 | 100-240
VAC +/-
10% | Single phase,
100-240V
50-60 Hz | Single phase,
100-240V
50-60 Hz |
| S.No | Parameters | SopranoICE
(K172193) | Lightsheer
Infinity
(K170179) | Primelase
Excellence
(K191321) | Primelase
Excellence
(Subject
device) |
| | | Hz, single
phase
220/230VAC,
6A, 50/60
Hz, single
phase | 15 A max.
50/60 Hz. | | |
8
High Technology Products SLU, Spain
5.7. Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:
-
- IEC 60601-1:2005 + AMD1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General 2. requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 62304:2006/AMD:2015 Medical device software software life cycle 3. processes
-
- IEC 60601-2-22 Edition 3.1: Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
-
- IEC60601-1-6 Edition 3.1: Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60825 1 Edition 2: Safety of laser products Part 1: Equipment 6. classification and requirements.
-
- ISO 14971:2007 Medical devices Application of risk management to medical devices.
-
- ISO 10993-5:2009 Biological Evaluation of Medical Device, Part 5-Tests for In Vitro cytotoxicity
-
- ISO 10993-10:2010 Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization
5.8. Clinical Testing
No clinical study is included in this submission.
9
High Technology Products SLU, Spain
5.9. Conclusion
Based on the comparison and analysis above, the PRIMELASE Excellence device's intended use and technological characteristics do not raise new types of questions regarding safety and efficacy when compared to the predicates. Based on its technical characteristics, indications for use, and performance data, the PRIMELASE Excellence device is considered to be substantially equivalent to the predicate devices.