(339 days)
Not Found
Not Found
No
The provided text describes various IPL and laser handpieces and their intended uses for dermatological and podiatric treatments. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML. The descriptions focus on the physical characteristics of the handpieces (wavelengths, filters) and the conditions they are intended to treat.
Yes.
The device's intended uses include "treatment of moderate inflammatory acne vulgaris," "treatment of benign pigmented epidermal lesions," and "temporary relief of minor muscle pain and joint pain," which are all therapeutic claims.
No
The document describes various 'Intended Use / Indications for Use' for different handpieces and filters of a device, all of which pertain to treatment of various skin conditions and for hair removal, and not for diagnosing them. The text explicitly lists therapeutic applications such as "The treatment of moderate inflammatory acne vulgaris," "The treatment of benign pigmented epidermal lesions," "The removal of unwanted hair," and "coagulation and hemostasis." There is no mention of the device being used to identify or characterize diseases or conditions.
No
The provided text describes various handpieces and their intended uses for treating a wide range of dermatological and podiatric conditions using IPL, IR, and laser technologies. These are hardware-based energy delivery devices, not software-only medical devices.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This includes things like blood, urine, tissue biopsies, etc., to provide information about a person's health or condition.
- The intended uses described for this device involve direct treatment of the human body using light energy (IPL and laser). The treatments listed are for various skin conditions, hair removal, and pain relief. These are all therapeutic applications, not diagnostic ones that involve analyzing samples outside the body.
The device is clearly a therapeutic device used for various dermatological and podiatric procedures.
N/A
Intended Use / Indications for Use
IPL 400nm - 1200nm Filter
The treatment of moderate inflammatory acne vulgaris;
The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles):
the treatment of benign 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 of rosacea, angiomas, Poikiloderma of Civatte, leg veins and venous malformations.
Use on all skin types (Fitzpatrick I-VI).
IPL 515-1200nm Filter
The treatment of moderate inflammatory acne (acne vulgaris).
The treatment of tattoos and benign pigmented epidermal and benign cutaneous lesions including warts, scars, striae, dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.
The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair growth 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 Fitzpatrick skin types I-V.
IPL 540nm-1200nm Filter
benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles),
lentigines, nevi, and cafe-au-lait macules;
the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.
The treatment of benign cutaneous lesions including warts, scars and striae.
The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair growth 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 all skin types (Fitzpatrick I-VI).
IPL 580nm-1200nm Filter
The treatment of moderate inflammatory acne vulgaris.
The treatment of benign pigmented lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).
The treatment of face and body vascular and benign pigmented lesions.
The treatment of benign 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 in hair growth 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.
IPL 640nm-1200nm Filter
the treatment of tattoos;
The treatment of mild to moderate inflammatory and pustular inflammatory acne vulgaris;
The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait;
the treatment of benign 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 of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations:
removal of unwanted hair, for stable long term or permanent hair reduction (permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treament regimen).
Use on all skin types (Fitzpatrick I-VI), including tanned skin.
IPL 695nm-1200nm Filter
removal of unwanted hair, for stable long term or permanent hair reduction (permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen).
Use on all skin types (Fitzpatrick I-VI), including tanned skin.
Intense IR Handpiece
intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature. It's also indicated for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms and strains, and minor muscular back pain.
1064 LongPulse Handpiece
removal of unwanted hair, for stable long term or permanent hair reatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime:
Treatment of pseudofolliculitis barbae (PFB)
Benign vascular lesions such as, but not limited to treatment of: Port wine stains; Hemangiomas; Warts; Superficial and deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas
Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Sebortheic keratoses; Nevi and nevus of Ota; Chloasma; verrucae, skin tags, keratoses, the removal of black, blue, or green tattoos (significant reduction in the intensity of black and/or blue/black tattoos, plaques
Benign cutaneous lesions, such as, but not limited to warts, scars, striae and psoriasis Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The non-ablative treatment of facial wrinkles, such as, but not limited to:
Periocular wrinkles
Perioral wrinkles
Laser skin resurfacing procedures for the treatment of:
Acne scars
Wrinkles
reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar
1064 LongPulse Handpiece Short Pulse Operation
intended for the coagulation and hemostasis of benign vascular lesions such as but not limited to, rosaceal diffuse redness, poikiloderma of civatte, scar reduction (including hypertropic and keloidscars), and warts.
is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
For use on all skin types (Fitzpatrick I-VI), including tanned skin.
1064 Handpiece - Onychomycosis
podiatry (i.e. ablation, vaporization, excision, and coagulation of soft tissue) including matrixectomy, radical nail excision, periungual and subungual warts, plantar warts, neuromas,
temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.).
Acroma QS handpiece
The 1064 nm wavelength is indicated for:
treatment of benign vascular lesions such as (but not limited to): port wine stains; hemangiomas; warts; superficial and deep telangiectasias (venulectasias); reticular veins (0.1-4.0 mm diameter) of the leg; rosacea; venous lakes; leg veins; spider veins; Poikiloderma of Civatte; angiomas;
benign cutaneous lesions, such as, but not limited to: warts; scars; striae; psoriasis;
benign pigmented lesions such as, but not limited to: lentigos (sun lentigos (sun spots); cafe-au-lait macules; seborrheic keratoses; nevi and Nevus of Ota; chloasma; verrucae; skin tags;
keratoses; the removal of black, blue or green tattoos (significant reduction in the intensity of black and/or blue/black tattoos); plaques;
pigmented benign lesions to reduce lesions' size for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
the non-ablative treatment of facial wrinkles, including but not limited to: periocular wrinkles;
laser skin resurfacing procedures for the treatment of acne scars: wrinkles.
reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The 532 nm wavelength is indicated for:
incision, excision, ablation, vaporization of soft tissue;
tattoo removal: light blue, yellow, red; green;
benignvascular lesions: Hemangiomas (port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); angiomas (cherry, spider); telangiectasias; spider nevi;
benign pigmented lesions: cafe-au-lait macules; lentigines (senile and solar); freckles (ephelides); chloasma; nevi; nevus spillus; Nevus of Ota; Becker's Nevi;
other benign pigmented cutaneous lesions: verrucae; skin tags; keratoses; plaques
1540 GoSmooth Handpiece
The 1540 Fractional Non-ablative Laser Handpiece is intended for use in the coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
2940 DualMode Handpiece - non-fractional
DERMATOLOGY AND PLASTIC SURGERY
Skin resurfacing: Treatment of wrinkles: Epidermal nevi: Telangiectasia: Spider veins:
Actinic chelitis; Keloids; Verrucae; Skin tags;
Anal tags; Keratoses; Scar revision (including acne scars); Debulking benign tumors; Debulking cysts; Superficial skin lesions; : Diagnostic biopsies; Decubitus
ulcers;
PODIATRY Treatment of: Warts, plantar verrucae, large mosaic verrucae. Matrixectomy.
2940 DualMode Handpiece - fractional
skin resurfacing
1340 ProDeep Handpiece
non-ablative laser handpiece is intended for use in skin resurfacing
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONF, PDZ, ILY
Device Description
Not Found
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
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Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Not Found
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 logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and consists of a stylized caduceus symbol. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
April 20, 2018
Vydence Medical Industria E Comercio Ltda % Kathy Maynor Regulatory Consultant and US Agent Kathy Maynor 26 Rebecca Ct Homosassa, Florida 34446
Re: K171443
Trade/Device Name: Etherea MX 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, ONF, PDZ, ILY Dated: March 13, 2018 Received: March 13, 2018
Dear Kathy Maynor:
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. 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); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
K171443
Device Name Vydence Etherea MX
Indications for Use (Describe)
IPL 400nm - 1200nm Filter
· The treatment of moderate inflammatory acne vulgaris;
· The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles):
· the treatment of benign 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 of rosacea, angiomas, Poikiloderma of Civatte, leg veins and venous malformations.
· Use on all skin types (Fitzpatrick I-VI).
IPL 515-1200nm Filter
· The treatment of moderate inflammatory acne (acne vulgaris).
· The treatment of tattoos and benign pigmented epidermal and benign cutaneous lesions including warts, scars, striae, dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, and cafè-aulait macules. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg
telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair growth is defined as the long-term , stable reduction in the number of hairs regrowing when measured at 6,9 an 12 months after the completion of a treatment regime.
· Use on Fitzpatrick skin types I-V.
Type of Use (Select one or both, as applicable)
| 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
3
510(k) Number (if known)
K171443
Device Name Vydence Etherea MX
Indications for Use (Describe)
IPL 540nm-1200nm Filter
· benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles),
· lentigines, nevi, and cafe-au-lait macules;
· the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.
· The treatment of benign cutaneous lesions including warts, scars and striae.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair growth 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 all skin types (Fitzpatrick I-VI).
IPL 580nm-1200nm Filter
· The treatment of moderate inflammatory acne vulgaris.
· The treatment of benign pigmented esions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).
· The treatment of face and body vascular and benign pigmented lesions.
· The treatment of benign 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 in hair growth is defined as the long-term , stable reduction in the number of hairs regrowing when measured at 6,9 an 12 months after the completion of a treatment regime.
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.
4
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
5
510(k) Number (if known)
Device Name Vydence Etherea MX
Indications for Use (Describe)
IPL 640nm-1200nm Filter
· the treatment of tattoos;
• The treatment of mild to moderate inflammatory and pustular inflammatory acne vulgaris;
· The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait;
· the treatment of benign 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 of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations:
· removal of unwanted hair, for stable long term or permanent hair reduction (permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treament regimen).
· Use on all skin types (Fitzpatrick I-VI), including tanned skin.
IPL 695nm-1200nm Filter
· removal of unwanted hair, for stable long term or permanent hair reduction (permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen).
· Use on all skin types (Fitzpatrick I-VI), including tanned skin.
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
6
510(k) Number (if known)
K171443
Device Name Vydence Etherea MX
Indications for Use (Describe)
Intense IR Handpiece
· intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature. It's also indicated for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms and strains, and minor muscular back pain.
1064 LongPulse Handpiece
· removal of unwanted hair, for stable long term or permanent hair reatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime:
· Treatment of pseudofolliculitis barbae (PFB)
· Benign vascular lesions such as, but not limited to treatment of: Port wine stains; Hemangiomas; Warts; Superficial and deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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
7
510(k) Number (if known)
K171443
Device Name Vydence Etherea MX
Indications for Use (Describe)
1064 LongPulse Handpiece (continued)
· Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Sebortheic keratoses; Nevi and nevus of Ota; Chloasma; verrucae, skin tags, keratoses, the removal of black, blue, or green tattoos (significant reduction in the intensity of black and/or blue/black tattoos, plaques
· Benign cutaneous lesions, such as, but not limited to warts, scars, striae and psoriasis Pigmented lesions to reduce lesion size, for patients with lesions that would potentially
benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
- The non-ablative treatment of facial wrinkles, such as, but not limited to:
- · Periocular wrinkles
- Perioral wrinkles
- Laser skin resurfacing procedures for the treatment of:
- Acne scars
- Wrinkles
· reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar
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.
8
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
9
510(k) Number (if known)
K171443
Device Name Vydence Etherea MX
Indications for Use (Describe)
1064 LongPulse Handpiece Short Pulse Operation
· intended for the coagulation and hemostasis of benign vascular lesions such as but not limited to, rosaceal diffuse redness, poikiloderma of civatte, scar reduction (including hypertropic and keloidscars), and warts.
- · is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
- · For use on all skin types(Fitzpatrick I-VI), including tanned skin.
1064 Handpiece - Onychomycosis
· podiatry (i.e. ablation, vaporization, excision, and coagulation of soft tissue) including matrixectomy, radical nail excision, periungual and subungual warts, plantar warts, neuromas,
· temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.).
Acroma QS handpiece
The 1064 nm wavelength is indicated for:
· treatment of benign vascular lesions such as (but not limited to): port wine stains; hemangiomas; warts; superficial and deep telangiectasias (venulectasias); reticular veins (0.1-4.0 mm diameter) of the leg; rosacea; venous lakes; leg veins; spider veins; Poikiloderma of Civatte; angiomas;
· benign cutaneous lesions, such as, but not limited to: warts; scars; striae; psoriasis;
· benign pigmented lesions such as, but not limited to: lentigos (sun lentigos (sun spots); cafe-au-lait macules; seborrheic keratoses; nevi and Nevus of Ota; chloasma; verrucae; skin tags;
keratoses; the removal of black, blue or green tattoos (significant reduction in the intensity of black and/or blue/black tattoos); plaques;
· pigmented benign lesions to reduce lesions' size for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
· the non-ablative treatment of facial wrinkles, including but not limited to: periocular wrinkles;
- · laser skin resurfacing procedures for the treatment of acne scars: wrinkles.
- · reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- · indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
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)
10
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
11
510(k) Number (if known)
K171443
Device Name Vydence Etherea MX
Indications for Use (Describe)
Acroma QS handpiece (continued)
The 532 nm wavelength is indicated for:
· incision, excision, ablation, vaporization of soft tissue;
· tattoo removal: light blue, yellow, red; green;
· benignvascular lesions: Hemangiomas (port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); angiomas (cherry, spider); telangiectasias; spider nevi;
· benign pigmented lesions: cafe-au-lait macules; lentigines (senile and solar); freckles (ephelides); chloasma; nevi; nevus spillus; Nevus of Ota; Becker's Nevi;
· other benign pigmented cutaneous lesions: verrucae; skin tags; keratoses; plaques
1540 GoSmooth Handpiece
· The 1540 Fractional Non-ablative Laser Handpiece is intended for use in the coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
2940 DualMode Handpiece - non-fractional
· DERMATOLOGY AND PLASTIC SURGERY
Skin resurfacing: Treatment of wrinkles: Epidermal nevi: Telangiectasia: Spider veins:
Actinic chelitis; Keloids; Verrucae; Skin tags;
Anal tags; Keratoses; Scar revision (including acne scars); Debulking benign tumors; Debulking cysts; Superficial skin lesions; : Diagnostic biopsies; Decubitus
ulcers;
12
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
13
510(k) Number (if known)
Device Name Vydence Etherea MX
Indications for Use (Describe) 2940 DualMode Handpiece (continued) · PODIATRY Treatment of: Warts, plantar verrucae, large mosaic verrucae. Matrixectomy.
2940 DualMode Handpiece - fractional
· skin resurfacing
1340 ProDeep Handpiece
· non-ablative laser handpiece is intended for use in skin resurfacing
| 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