(122 days)
Not Found
No
The document describes a standard IPL device with different wavelength filters and does not mention any AI or ML components in the intended use, device description, or performance studies.
Yes.
The "Intended Use" section explicitly states it's for "aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology." The "Summary of Performance Studies" also mentions "IEC 60601-2-57 Edition 1.0 2011-01 Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use," directly stating its therapeutic intent. The indications for use also describe treating various medical conditions like vascular lesions and pigmented lesions.
No
The device is intended for aesthetic applications and treatment of various skin conditions and for hair removal, not for diagnosing diseases or conditions.
No
The device description explicitly states that the system consists of a system console, electronics and software, cooling system, and handpiece with six filters, indicating it includes significant hardware components beyond just software.
Based on the provided information, the Lucent : IPL device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue" and lists various skin conditions and hair removal as indications. This involves direct treatment of the patient's body using light energy.
- IVD Definition: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The Lucent : IPL does not perform any such tests on samples.
- Device Description: The description details a system that uses light energy (IPL) applied to the skin. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD-related information: The document does not mention any aspects typically associated with IVDs, such as sample handling, reagents, analytical methods, or diagnostic results.
Therefore, the Lucent : IPL is a therapeutic and aesthetic device that applies light energy to the body, not an IVD.
N/A
Intended Use / Indications for Use
The Lucent : IPL is Intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
Indication for Use for the 430-980nm wavelength
Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
For use on Fitzpatrick skin types (I-V)
Indication for use for the 515-980nm wavelength
Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles). and striae.
Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines.
For use on Fitzpatrick skin types (I-V)
Indication for use for the 560-980nm wavelength
Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines.
The removal of unwanted hair to effect stable long-term or permanent hair reduction
For use on Fitzpatrick skin types (I-V)
Indication for use for the 585-980nm wavelength
Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
The removal of unwanted hair to effect stable long-term or permanent hair reduction
For use on Fitzpatrick skin types (I-V)
Indication for use for the 640-980nm wavelength
Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
The removal of unwanted hair to effect stable long-term or permanent hair reduction
For use on Fitzpatrick skin types (I-V)
Indication for use for the 700-980nm wavelength
The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the 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
For use on Fitzpatrick skin types (I-V)
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
The LUVO Medical Technologies, Inc. Lucent : IPL is a multi-wavelength non-invasive system for IPL skin treatments, treatment of vascular and pigmented lesions, and hair removal using multiple filters reflecting a wavelength range of 430nm to 980nm. The Lucent : IPL system consists of a system console, electronics and software, cooling system, and handpiece with six filters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, epidermal and cutaneous lesions, hair
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)
The following performance data was provided in support of the substantial equivalence determination:
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 Edition 4.0 2014-02 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility
IEC 60601-2-57 Edition 1.0 2011-01 Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
Results of Clinical Study: A human clinical study was not required as the device is substantially equivalent to the predicate devices.
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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
LUVO Medical Technologies, Inc. Mr. Gregory Berzak Regulatory Affairs Officer 125 Fleming Dr Cambridge. N1T 2B8 Ca
Re: K193072
Trade/Device Name: Lucent : IPL 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: ONF Dated: October 28, 2019 Received: November 4, 2019
Dear Gregory Berzak:
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 (OS) 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,
Jessica Mavadia-Shukla 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
Enclosure
2
Indications for Use
510(k) Number (if known) K193072
Device Name
Lucent : IPL
Indications for Use (Describe)
The Lucent : IPL is Intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
Indication for Use for the 430-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
· For use on Fitzpatrick skin types (I-V)
Indication for use for the 515-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles). and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines.
· For use on Fitzpatrick skin types (I-V)
Indication for use for the 560-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction
· For use on Fitzpatrick skin types (I-V)
Indication for use for the 585-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
· Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction
· For use on Fitzpatrick skin types (I-V)
3
Indication for use for the 640-980nm wavelength
· Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
- · Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
- · The removal of unwanted hair to effect stable long-term or permanent hair reduction
- · For use on Fitzpatrick skin types (I-V)
Indication for use for the 700-980nm wavelength
• The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the 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
· For use on Fitzpatrick skin types (I-V)
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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4
This 510(K) Summary of safety and effectiveness for the Lucent : IPL is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | LUVO Medical Technologies, Inc. |
|---|---|
| Address: | LUVO Medical Technologies, Inc. |
| 125 Fleming Dr | |
| Cambridge, Ontario, Canada N1T 2B8 | |
| Contact Person: | Mr. Gregory Berzak |
| Telephone: | 519-6203900- phone |
| gregoryb@clarionmedical.com | |
| Preparation Date: | October 15, 2019 |
| Device Trade Name: | Lucent : IPL |
| Common Name: | Powered light based non-laser surgical instrument with |
| thermal effect | |
| Regulation Name: | Laser surgical instrument for use in general and |
| plastic surgery and dermatology | |
| Regulation Number: | 21 CFR 878.4810 (Product Code: ONF) |
| Legally Marketed Predicate Devices: | Primary Predicate : Alma Harmony XL Multi-Application |
| Platform / Secondary Predicate: Lumenis M22 System | |
| 510(K) number: | K072564/ K142860 |
| Regulatory Class: | Class II Prescription Use |
| Description of the Lucent : IPL: | The LUVO Medical Technologies, Inc. Lucent : IPL isa |
| multi-wavelength non-invasive system for IPL skin | |
| treatments, treatment of vascular and pigmented lesions, | |
| and hair removal using multiple filters reflecting a | |
| wavelength range of 430nm to 980nm. | |
| The Lucent : IPL system consists of a system console, | |
| electronics and software, cooling system, and handpiece | |
| with six filters | |
| Intended use of Lucent : IPL: | The Lucent : IPL is intended for use in dermatologicand |
| general surgical procedures. See the below Indications for | |
| Use Comparison Table. | |
| Performance Data: | The following performance data was provided in support |
| of | |
| 5-1 |
5
the substantial equivalence determination:
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 Edition 4.0 2014-02 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility
IEC 60601-2-57 Edition 1.0 2011-01 Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
Results of Clinical Study:
A human clinical study was not required as the device is substantially equivalent to the predicate devices.
Technical Specifications / Indications for Use Comparison:
| | 510(K) Submission
Lucent : IPL
(K193072) | Predicate
K142860 - Lumenis
M22 System |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | | |
| Wavelength
(nm) | 430-980nm | 400-1200nm |
| Intended Use | Intended for use in aesthetic
applications requiring selective
photothermolysis
(photocoagulation or coagulation)
and hemostasis of soft tissue in the
medical specialties of general
and plastic surgery, and
dermatology | Intended for use in aesthetic and cosmetic
applications requiring selective photothermolysis
(photocoagulation or coagulation) and hemostasis of
soft tissue in the medical specialties of general
and plastic surgery, and dermatology |
6
| Indications for
Use | Benign pigmented
epidermal and cutaneous
lesions including
dyschromia,
hyperpigmentation,
melasma, Ephelides
(freckles), and striae. Benign cutaneous vascular
lesions, including port wine
stains, hemangiomas, facial
and truncal telangiectasias,
angiomas and spider
angiomas, and
poikiloderma of Civatte. For use on Fitzpatrick skin
types (I-V) | Mild to Moderate inflammatory
(Acne Vulgaris) Benign epidermal
lesions, including dyschromia,
hyperpigmentation, melasma,
ephelides (freckles) and tattoos Cutaneous lesions, including warts,
scars and striae Benign cutaneous vascular lesions,
including port wine stains,
hemangiomas, facial, truncal and leg
telangiectasias, Erythema of rosacea, angiomas and
spider angiomas, poikiloderma of
Civatte, leg veins and venous
malformations Removal of unwanted hair from all
skin types, and to effect stable long
term, or permanent* hair reduction in
skin types I-V through selective targeting of
melanin in hair follicles |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulse Width
(msec) | 3-35 | 4-20 |
| Energy
Density
(Fluence)
(J/cm2) | 6-40 | 10-35 |
| Spot Size
(mm) | 15mm x 40mm | 15mm x 35mm / 8mm x 15mm |
| | 510(K) Submission
Lucent : IPL
(K193072) | Predicate
K072564 - Alma
VL515 IPL handpiece |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | | |
| Wavelength
(nm) | 515-980nm | 515nm-950nm |
| Intended Use | Intended for use in aesthetic
applications requiring selective
photothermolysis
(photocoagulation or coagulation)
and hemostasis of soft tissue in the
medical specialties of general
and plastic surgery, and
dermatology | Intended for use in aesthetic and cosmetic
applications requiring selective photothermolysis
(photocoagulation or coagulation) and hemostasis of
soft tissue in the medical specialties of general
and plastic surgery, and dermatology |
7
| Indications for
Use | • Benign pigmented
epidermal and cutaneous
lesions including
dyschromia,
hyperpigmentation,
melasma, Ephelides
(freckles), and striae.
• Benign cutaneous vascular
lesions, including port wine
stains, hemangiomas, facial
and truncal telangiectasias,
angiomas and spider
angiomas, poikiloderma of
Civatte and Lentigines
• For use on Fitzpatrick skin
types (I-V) | • Moderate inflammatory acne (acne
vulgaris)
• Tattoos and benign pigmented epidermal
and cutaneous lesions including warts,
scars ,striae; dyschromia,
hyperpigmentation, melasma, epithelides
(freckles), lentigines, nevi, and café-au-lait
macules
• Benign cutaneous vascular lesions,
including port wine stains,hemangiomas,
facial, truncal and legtelangiectasias,
rosacea, erythema of rosacea, angiomas and
spider angiomas, poikiloderma of Civatte,
leg veins and venous malformations
• For use on skin types(I-V) |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulse Width
(msec) | 3-35 | 10-15 |
| Energy
Density
(Fluence)
$(J/cm2)$ | 6-40 | 10-30 |
| Spot Size
(mm) | 15mm x 40mm | 3cm2 and 6.4 cm2 |
| | 510(K) Submission
Lucent : IPL
(K193072) | Predicate
K072564 - Alma IPL handpiece VL/PL, VP
and SSR |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | | |
| Wavelength | 560-980nm | 540-950nm |
| Intended Use | Intended for use in aesthetic
applications requiring selective
photothermolysis (photocoagulation or
coagulation) and hemostasis of soft
tissue in the medical specialties of
general
and plastic surgery, and dermatology | Intended for use in aesthetic and cosmetic
applications requiring selective
photothermolysis (photocoagulation or
coagulation) and hemostasis of soft tissue in
the medical specialties of general and plastic
surgery, and dermatology |
8
| Indications for Use | Benign pigmented epidermal and
cutaneous lesions including
dyschromia, hyperpigmentation,
melasma, Ephelides (freckles),
and striae. Benign cutaneous vascular
lesions, including port wine
stains, hemangiomas, facial and
truncal telangiectasias, angiomas
and spider angiomas,
poikiloderma of Civatte and
Lentigines The removal of unwanted hair to
effect stable long-term or
permanent hair reduction For use on Fitzpatrick skin types
(I-V) | The treatment of moderate
inflammatory acne vulgaris. The treatment of benign pigmented
epidermal lesions including dyschromia,
hyperpigmentation, melasma, and
ephelides (freckles), lentigines, nevi,
melasma, and cafe-au-lait macules. The treatment of cutaneous
lesions including warts, scars and
striae. The treatment of benign cutaneous
vascular lesions including port wine
stains, hemangiomas, facial, truncal and
leg telangiectasias, rosacea, erythema or
rosacea, angiomas and spider angiomas,
poikiloderma of Civatte, leg veins and
venous malformations. The removal of unwanted hair to
effect stable long-term or permanent hair
reduction. Use on all skin types (Fitzpatrick I-VI). |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulse Width
(msec) | 3-35 | 10-15 |
| Energy Density
(Fluence)
(J/cm2) | 6-40 | 1-15 and 10-30 |
| Spot Size
(mm) | 15mm x 40mm | 3 cm2 |
| | 510(K) Submission
Lucent : IPL
(K193072) | Predicate K072564 –
Alma
SR IPL handpiece |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | | |
| Wavelength
(nm) | 585-980nm | 570-950nm |
| Intended Use | Intended for use in aesthetic applications
requiring selective photothermolysis
(photocoagulation or coagulation) and
hemostasis of soft tissue in the medical
specialties of general and plastic surgery,
and dermatology | Intended for use in aesthetic and cosmetic
applications requiring selective photothermolysis
(photocoagulation or coagulation) and hemostasis
of soft tissue in the medical specialties of general
and plastic
surgery, and dermatology |
9
| Indications for
| Use | Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte. The removal of unwanted hair to effect stable long-term or permanent hair reduction. For use on Fitzpatrick skin types (I-V) | The treatment of moderate inflammatory acnevulgaris. The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). The treatment of face and body vascular and pigmentedlesions. The treatment of cutaneous lesions, including scars and striae. The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. The removal of unwanted hair to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI). |
|---|---|---|
| Pulse Width | ||
| (msec) | 3-35 | 10-15 |
| Energy | ||
| Density | ||
| (Fluence) | ||
| (J/cm2) | 6-40 | 10-25 |
| Spot Size | ||
| (mm) | 15mm x 40mm | 6.4 cm2 |
| | 510(K) Submission
Lucent : IPL
(K193072) | Predicate
K072564 - Alma
HR Module AFT
Handpiece |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | | |
| Wavelength
(nm) | 640-980nm | 650-950nm |
| Intended Use | Intended for use in aesthetic applications
requiring selective photothermolysis
(photocoagulation or coagulation) and
hemostasis of soft tissue in the medical
specialties of general and plastic surgery,
and dermatology | Intended for use in aesthetic and cosmetic
applications requiring selective photothermolysis
(photocoagulation or coagulation) and hemostasis
of soft tissue in the medical specialties of general
and plastic
surgery, and dermatology |
10
| Indications for
| Use | Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte. The removal of unwanted hair to effect stable long-term or permanent hair reduction. For use on Fitzpatrick skin types (I-V) | The treatment of moderate inflammatory acnevulgaris. The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). The treatment of face and body vascular and pigmentedlesions. The treatment of cutaneous lesions, including scars and striae. The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. The removal of unwanted hair to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI) |
|---|---|---|
| Pulse Width | ||
| (msec) | 3-35 | 30-50 |
| Energy | ||
| Density | ||
| (Fluence) | ||
| (J/cm2) | 6-40 | 5-25 |
| Spot Size | ||
| (mm) | 15mm x 40mm | 6.4 cm² |
| | 510(K) Submission
Lucent : IPL
(K193072) | Predicate
K072564 - Alma SHR IPL |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | | |
| Wavelength
(nm) | 700-980nm | 780-950nm |
| Intended Use | Intended for use in aesthetic applications
requiring selective photothermolysis
(photocoagulation or coagulation) and
hemostasis of soft tissue in the medical
specialties of general
and plastic surgery, and dermatology | Intended for use in aesthetic and cosmetic
applications requiring selective
photothermolysis (photocoagulation or
coagulation) and hemostasis of soft tissue in
the medical specialties of general and
plastic surgery, and
dermatology |
11
| Indications for Use | |||
|---|---|---|---|
| The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long- term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime Use on skin types (Fitzpatrick I-V) | The treatment of pseudofolliculitis barbae(PFB). The removal of unwanted hair and to effect stable long-term or permnanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tannedskin. | ||
| Pulse Width | |||
| (msec) | 3-35 | ≤30msec/1,3 and 30 sec | ≤6msec |
| Energy Density | |||
| (Fluence) | |||
| (J/cm2) | 6-40 | 1-7 and 0.5-1.5 | 1-7 |
| Spot Size | |||
| (mm) | 15mm x 40mm | 3 cm2 | 6.4 cm2 |
The Lucent : IPL's intended use, indications for use and technical specifications Conclusion: are substantially equivalent to the Harmony XL Multi-Application Platform and the M22 System.