(122 days)
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)
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
The provided text is a 510(k) premarket notification summary for the Lucent : IPL device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are explicitly stated as not applicable or not required in this type of submission.
Here's a breakdown based on the provided document:
Acceptance Criteria and Device Performance for Lucent : IPL
The device, Lucent : IPL, did not undergo a de novo clinical study with specific acceptance criteria in the typical sense for this 510(k) submission. Instead, its performance and safety are established by demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" here are implicitly linked to showing that its technical specifications and indications for use fall within the established range or scope of the predicates, and that any differences do not raise new questions of safety or effectiveness.
1. A table of acceptance criteria and the reported device performance:
Since no specific performance metrics with predefined acceptance criteria from a de novo study are presented, the "acceptance criteria" are the ranges and types of indications provided by the predicate devices. The "reported device performance" is the Lucent : IPL's own specifications.
| Characteristic | Predicate K142860 (Lumenis M22 System) | Predicate K072564 (Alma Harmony XL Multi-Application Platform) | Lucent : IPL (K193072) Reported Performance | Notes on Equivalence |
|---|---|---|---|---|
| Wavelength (nm) | 400-1200nm (Varies by handpiece) | 515-950nm (Varies by handpiece) | 430-980nm (Across 6 filters) | The Lucent : IPL wavelength ranges often overlap or fall within the combined ranges of the predicate devices. |
| Intended Use | Aesthetic & cosmetic applications requiring selective photothermolysis (photocoagulation/coagulation) and hemostasis of soft tissue in general/plastic surgery and dermatology. | Same as K142860. | Same as K142860. | Verbally identical. |
| Indications for Use (General) | Benign epidermal/cutaneous lesions, vascular lesions, hair removal, moderate inflammatory acne (Predicate K142860 only). | Benign epidermal/cutaneous lesions, vascular lesions, hair removal, moderate inflammatory acne (Predicate K072564 only). | Benign pigmented epidermal/cutaneous lesions (dyschromia, hyperpigmentation, melasma, ephelides, striae, lentigines) and Benign cutaneous vascular lesions (port wine stains, hemangiomas, facial/truncal telangiectasias, angiomas/spider angiomas, poikiloderma of Civatte). Also includes permanent hair reduction for specific wavelengths. | The Lucent : IPL's indications are a subset of or align with those of the predicate devices. The document highlights the specific conditions addressed by each wavelength of the Lucent : IPL. |
| Pulse Width (msec) | 4-20 (K142860); 10-15 (K072564, specific handpieces); 30-50 (K072564, specific handpieces); ≤30msec/1,3 and 30 sec (K072564, specific handpieces); ≤6msec (K072564, specific handpieces). | Varies by handpiece, examples: 10-15 msec, 30-50 msec, etc. | 3-35 msec | The Lucent : IPL's pulse width range (3-35 msec) overlaps considerably with pulse widths of the predicate devices. |
| Energy Density (Fluence) (J/cm²) | 10-35 J/cm² (K142860); 10-30 J/cm² (K072564, specific handpieces); 1-15 J/cm² / 10-30 J/cm² (K072564, specific handpieces); 10-25 J/cm² (K072564, specific handpieces); 5-25 J/cm² (K072564, specific handpieces); 1-7 J/cm² / 0.5-1.5 J/cm² (K072564, specific handpieces). | Varies by handpiece, examples: 10-30 J/cm², 1-15 J/cm², etc. | 6-40 J/cm² | The Lucent : IPL's energy density range (6-40 J/cm²) encompasses or overlaps with the ranges of the predicate devices. |
| Spot Size (mm) | 15mm x 35mm / 8mm x 15mm (K142860); 3cm² / 6.4 cm² (K072564, specific handpieces). | Varies by handpiece, examples: 3 cm², 6.4 cm². | 15mm x 40mm | The Lucent : IPL's spot size is comparable to and falls within the realm of spot sizes offered by predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. A human clinical study (test set) was explicitly not required for this 510(k) submission, as stated in the document ("Results of Clinical Study: A human clinical study was not required as the device is substantially equivalent to the predicate devices.").
- Data Provenance: Not applicable, as no clinical study was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical study was performed and no "ground truth" for a test set was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical study was performed and no "ground truth" for a test set was established.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an IPL system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device for treatment, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The basis for clearance is substantial equivalence to existing legally marketed predicate devices, meaning that the device's technical specifications and indications for use are similar enough not to raise new safety or effectiveness concerns. The "ground truth" in this context is the FDA's prior clearance of the predicate devices based on their established safety and effectiveness.
8. The sample size for the training set:
- Not applicable. This refers to AI/ML development, which is not relevant to this type of device and submission.
9. How the ground truth for the training set was established:
- Not applicable. This refers to AI/ML development, which is not relevant to this type of device and submission.
Summary of the Study Proving Device Meets Acceptance Criteria:
The "study" proving the Lucent : IPL meets acceptance criteria is the 510(k) premarket notification review process, which involved:
- Comparison to Predicate Devices: The submission meticulously compares the Lucent : IPL's technical specifications (wavelength, intended use, indications for use, pulse width, energy density, spot size) to two predicate devices:
- Performance Testing (Non-Clinical): The document states that the following performance data was provided:
- ES60601-1:2005/(R)2012 and A1:2012 Test for Medical Electrical equipment (General Requirements for basic safety and essential performance)
- IEC 60601-1-2 Edition 4.0 2014-02 Test for Medical Equipment (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)
The conclusion, explicitly stated in the document, is: "The Lucent : IPL's intended use, indications for use and technical specifications are substantially equivalent to the Harmony XL Multi-Application Platform and the M22 System." This "substantial equivalence" is the "proof" accepted by the FDA for clearance in this case, rather than a de novo clinical study with specific performance metrics.
{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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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 DrCambridge, Ontario, Canada N1T 2B8 |
| Contact Person: | Mr. Gregory Berzak |
| Telephone: | 519-6203900- phonegregoryb@clarionmedical.com |
| Preparation Date: | October 15, 2019 |
| Device Trade Name: | Lucent : IPL |
| Common Name: | Powered light based non-laser surgical instrument withthermal effect |
| Regulation Name: | Laser surgical instrument for use in general andplastic surgery and dermatology |
| Regulation Number: | 21 CFR 878.4810 (Product Code: ONF) |
| Legally Marketed Predicate Devices: | Primary Predicate : Alma Harmony XL Multi-ApplicationPlatform / 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 isamulti-wavelength non-invasive system for IPL skintreatments, treatment of vascular and pigmented lesions,and hair removal using multiple filters reflecting awavelength range of 430nm to 980nm. |
| The Lucent : IPL system consists of a system console,electronics and software, cooling system, and handpiecewith six filters | |
| Intended use of Lucent : IPL: | The Lucent : IPL is intended for use in dermatologicandgeneral surgical procedures. See the below Indications forUse Comparison Table. |
| Performance Data: | The following performance data was provided in supportof5-1 |
{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) SubmissionLucent : IPL(K193072) | PredicateK142860 - LumenisM22 System | |
|---|---|---|
| Characteristic | ||
| Wavelength(nm) | 430-980nm | 400-1200nm |
| Intended Use | Intended for use in aestheticapplications requiring selectivephotothermolysis(photocoagulation or coagulation)and hemostasis of soft tissue in themedical specialties of generaland plastic surgery, anddermatology | Intended for use in aesthetic and cosmeticapplications requiring selective photothermolysis(photocoagulation or coagulation) and hemostasis ofsoft tissue in the medical specialties of generaland plastic surgery, and dermatology |
{6}------------------------------------------------
| Indications forUse | Benign pigmentedepidermal and cutaneouslesions includingdyschromia,hyperpigmentation,melasma, Ephelides(freckles), and striae. Benign cutaneous vascularlesions, including port winestains, hemangiomas, facialand truncal telangiectasias,angiomas and spiderangiomas, andpoikiloderma of Civatte. For use on Fitzpatrick skintypes (I-V) | Mild to Moderate inflammatory(Acne Vulgaris) Benign epidermallesions, 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 legtelangiectasias, Erythema of rosacea, angiomas andspider angiomas, poikiloderma ofCivatte, leg veins and venousmalformations Removal of unwanted hair from allskin types, and to effect stable longterm, or permanent* hair reduction inskin types I-V through selective targeting ofmelanin in hair follicles |
|---|---|---|
| Pulse Width(msec) | 3-35 | 4-20 |
| EnergyDensity(Fluence)(J/cm2) | 6-40 | 10-35 |
| Spot Size(mm) | 15mm x 40mm | 15mm x 35mm / 8mm x 15mm |
| 510(K) SubmissionLucent : IPL(K193072) | PredicateK072564 - AlmaVL515 IPL handpiece | |
|---|---|---|
| Characteristic | ||
| Wavelength(nm) | 515-980nm | 515nm-950nm |
| Intended Use | Intended for use in aestheticapplications requiring selectivephotothermolysis(photocoagulation or coagulation)and hemostasis of soft tissue in themedical specialties of generaland plastic surgery, anddermatology | Intended for use in aesthetic and cosmeticapplications requiring selective photothermolysis(photocoagulation or coagulation) and hemostasis ofsoft tissue in the medical specialties of generaland plastic surgery, and dermatology |
{7}------------------------------------------------
| Indications forUse | • Benign pigmentedepidermal and cutaneouslesions includingdyschromia,hyperpigmentation,melasma, Ephelides(freckles), and striae.• Benign cutaneous vascularlesions, including port winestains, hemangiomas, facialand truncal telangiectasias,angiomas and spiderangiomas, poikiloderma ofCivatte and Lentigines• For use on Fitzpatrick skintypes (I-V) | • Moderate inflammatory acne (acnevulgaris)• Tattoos and benign pigmented epidermaland cutaneous lesions including warts,scars ,striae; dyschromia,hyperpigmentation, melasma, epithelides(freckles), lentigines, nevi, and café-au-laitmacules• Benign cutaneous vascular lesions,including port wine stains,hemangiomas,facial, truncal and legtelangiectasias,rosacea, erythema of rosacea, angiomas andspider angiomas, poikiloderma of Civatte,leg veins and venous malformations• For use on skin types(I-V) |
|---|---|---|
| Pulse Width(msec) | 3-35 | 10-15 |
| EnergyDensity(Fluence)$(J/cm2)$ | 6-40 | 10-30 |
| Spot Size(mm) | 15mm x 40mm | 3cm2 and 6.4 cm2 |
| 510(K) SubmissionLucent : IPL(K193072) | PredicateK072564 - Alma IPL handpiece VL/PL, VPand SSR | |
|---|---|---|
| Characteristic | ||
| Wavelength | 560-980nm | 540-950nm |
| Intended Use | Intended for use in aestheticapplications requiring selectivephotothermolysis (photocoagulation orcoagulation) and hemostasis of softtissue in the medical specialties ofgeneraland plastic surgery, and dermatology | Intended for use in aesthetic and cosmeticapplications requiring selectivephotothermolysis (photocoagulation orcoagulation) and hemostasis of soft tissue inthe medical specialties of general and plasticsurgery, and dermatology |
{8}------------------------------------------------
| Indications for Use | Benign pigmented epidermal andcutaneous lesions includingdyschromia, hyperpigmentation,melasma, Ephelides (freckles),and striae. Benign cutaneous vascularlesions, including port winestains, hemangiomas, facial andtruncal telangiectasias, angiomasand spider angiomas,poikiloderma of Civatte andLentigines The removal of unwanted hair toeffect stable long-term orpermanent hair reduction For use on Fitzpatrick skin types(I-V) | The treatment of moderateinflammatory acne vulgaris. The treatment of benign pigmentedepidermal lesions including dyschromia,hyperpigmentation, melasma, andephelides (freckles), lentigines, nevi,melasma, and cafe-au-lait macules. The treatment of cutaneouslesions including warts, scars andstriae. The treatment of benign cutaneousvascular lesions including port winestains, hemangiomas, facial, truncal andleg telangiectasias, rosacea, erythema orrosacea, angiomas and spider angiomas,poikiloderma of Civatte, leg veins andvenous malformations. The removal of unwanted hair toeffect stable long-term or permanent hairreduction. 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) SubmissionLucent : IPL(K193072) | Predicate K072564 –AlmaSR IPL handpiece | |
|---|---|---|
| Characteristic | ||
| Wavelength(nm) | 585-980nm | 570-950nm |
| Intended Use | Intended for use in aesthetic applicationsrequiring selective photothermolysis(photocoagulation or coagulation) andhemostasis of soft tissue in the medicalspecialties of general and plastic surgery,and dermatology | Intended for use in aesthetic and cosmeticapplications requiring selective photothermolysis(photocoagulation or coagulation) and hemostasisof soft tissue in the medical specialties of generaland plasticsurgery, and dermatology |
{9}------------------------------------------------
| Indications forUse | 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 |
| EnergyDensity(Fluence)(J/cm2) | 6-40 | 10-25 |
| Spot Size(mm) | 15mm x 40mm | 6.4 cm2 |
| 510(K) SubmissionLucent : IPL(K193072) | PredicateK072564 - AlmaHR Module AFTHandpiece | |
|---|---|---|
| Characteristic | ||
| Wavelength(nm) | 640-980nm | 650-950nm |
| Intended Use | Intended for use in aesthetic applicationsrequiring selective photothermolysis(photocoagulation or coagulation) andhemostasis of soft tissue in the medicalspecialties of general and plastic surgery,and dermatology | Intended for use in aesthetic and cosmeticapplications requiring selective photothermolysis(photocoagulation or coagulation) and hemostasisof soft tissue in the medical specialties of generaland plasticsurgery, and dermatology |
{10}------------------------------------------------
| Indications forUse | 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 |
| EnergyDensity(Fluence)(J/cm2) | 6-40 | 5-25 |
| Spot Size(mm) | 15mm x 40mm | 6.4 cm² |
| 510(K) SubmissionLucent : IPL(K193072) | PredicateK072564 - Alma SHR IPL | |
|---|---|---|
| Characteristic | ||
| Wavelength(nm) | 700-980nm | 780-950nm |
| Intended Use | Intended for use in aesthetic applicationsrequiring selective photothermolysis(photocoagulation or coagulation) andhemostasis of soft tissue in the medicalspecialties of generaland plastic surgery, and dermatology | Intended for use in aesthetic and cosmeticapplications requiring selectivephotothermolysis (photocoagulation orcoagulation) and hemostasis of soft tissue inthe medical specialties of general andplastic surgery, anddermatology |
{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.
§ 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.