(236 days)
The Aerolase Nd:YAG Laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery, podiatry, and urology for surgical and aesthetic applications.
Dermatology:
The Aerolase Nd:YAG Laser is intended for the coagulation and hemostasis of benian vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte: and treatment of benian cutaneous lesions, such as warts, scars, striae, debridement of decubitus ulcer, treatment of keloids, and psoriasis. The laser is also intended for the treatment of benian pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
Additionally, the Aerolase Nd:YAG Laser is indicated for 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 Aerolase Nd:YAG Laser is also indicated for the treatment of wrinkles, such as. but not limited to, periocular and perioral wrinkles.
The Aerolase Nd:YAG Laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Aerolase Nd:YAG Laser is also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The Aerolase Nd: YAG Laser is also indicated for the removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). Permanent hair reduction 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.
The Aerolase Nd:YAG Laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Podiatry:
Podiatry (ablation, vaporization, incision, excision, and coaqulation of soft tissue), including:
- . Matrixectomy:
- . Periungual and subungual warts:
- Plantar warts: ●
- Radical nail excision; ◆
- Neuromas. .
General Surgery:
The Aerolase Nd: YAG Laser is indicated for the incision/excision and cutting, ablation, coaqulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy gastroenterology, general surgery, head and neck/otolaryngology (ENT) neurosurgery, oculaplastics, orthopedics, plastic surgery, pulmonary/ thoracic surgery, gynecology (e.g. menorrhagia), podiatry and urology. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
The Aerolase Nd:YAG 1064nm Laser is Neodynmium doped Yttriuim-Aluminum-Garnet ("Nd:YAG") Laser. This device consists of the following components and accessories: a power supply unit with an air-cooling system, and a laser hand piece connected to the power supply/air cooling system using umbilical cords. Laser parameters are controlled from a display panel located on the front of the power supply unit.
Here's a breakdown of the acceptance criteria and study information for the Aerolase Model Nd:YAG 1064nm Laser, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device cleared in 2012. Historically, such summaries, especially for predicate device clearances, often focused on demonstrating safety and effectiveness through substantial equivalence to existing devices, relying heavily on compliance with recognized standards and published clinical data rather than novel clinical trials with specific statistical endpoints. This document reflects that approach.
Acceptance Criteria and Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics from new clinical studies. Instead, it relies on demonstrating compliance with specified standards and leveraging existing published clinical data to support safety and effectiveness.
Acceptance Criteria (Implied by the context of a 510(k) and provided text):
| Acceptance Criteria Category | Description | Reported Device Performance/Evidence |
|---|---|---|
| Safety and Effectiveness | The device must be as safe and effective as its predicate devices for the stated intended uses/indications for use. | "The Aerolase Nd:YAG 1064nm Laser is as safe and effective as the identified predicate devices listed above." "Performance data demonstrate that the Aerolase Nd:YAG 1064nm Laser is as safe and effective as the predicate devices." Implied to be supported by compliance with standards and published clinical data, as no new clinical study data with specific endpoints are presented. |
| Technological Equivalence | The device must have the same technological characteristics and principles of operation as its predicate devices, or any differences must not raise new questions of safety or effectiveness. | "The Aerolase Nd: YAG 1064nm Laser has the same intended uses / indications for use, technological characteristics, and principles of operation as its predicate devices." |
| Compliance with Standards | The device must comply with recognized national and international standards for electrical safety, laser safety, and medical device design. | "Product testing was performed to confirm compliance with the following standards: 21 C.F.R. 1040, IEC-60601-1, IEC-60601-2, IEC-60601-2-22, and IEC-60825-1. In all instances, the Aerolase 1064nm Laser functioned as intended and results observed were as expected." |
| Clinical Efficacy (for specified applications) | While not detailed in this summary, for an Nd:YAG laser to be cleared for various dermatological and surgical applications, there would be an underlying assumption that its performance parameters (wavelength, pulse duration, fluence, spot size) are within ranges known to be clinically effective for those indications. | "published clinical data supports the safe and effective use of this device." This refers to existing literature for Nd:YAG lasers in general, not specific new clinical data generated for this device. |
Study Information (Based on the Provided Document)
This 510(k) summary does not describe a new, standalone clinical study conducted specifically for the Aerolase Model Nd:YAG 1064nm Laser to establish its safety and effectiveness against explicit acceptance criteria using a test set as typically understood in AI/ML performance evaluation. Instead, it relies on:
- Substantial Equivalence: Comparing the device to predicate devices.
- Compliance with Standards: Demonstrating the device meets established safety and performance standards relevant to a laser.
- Published Clinical Data: Referring to existing literature that supports the general use of Nd:YAG lasers for the claimed indications.
Therefore, many of the specific questions about sample sizes, ground truth establishment, and expert involvement for a new study cannot be answered from this document.
1. Sample sizes used for the test set and the data provenance:
* Test Set Sample Size: Not applicable. No new "test set" from a clinical study for this specific device is described.
* Data Provenance: Not applicable. The document refers to "published clinical data," which would be from various sources (countries, prospective/retrospective), but doesn't specify data provenance for a study unique to this device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. No new test set with expert-established ground truth is described for this device. The "ground truth" for the device's efficacy is implicitly established by the broad body of existing medical literature supporting Nd:YAG laser use in specified procedures, reviewed by the FDA as part of the 510(k) process.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable. No new test set requiring adjudication is described.
4. 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:
* No. This device is a laser system, not an AI/ML diagnostic tool involving human readers or AI assistance in interpretation. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* No. This is a physical laser device, not a software algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* For the general efficacy of Nd:YAG lasers in the indicated applications, the "ground truth" would be clinical outcomes (e.g., reduction in lesion size, hair reduction, successful coagulation/hemostasis, pathology reports where applicable for lesion confirmation), established over years of medical practice and reported in peer-reviewed literature. For this specific 510(k), the ground truth is primarily established through substantial equivalence to legally marketed predicate devices further supported by compliance with recognized standards and broad published clinical data relating to Nd:YAG lasers.
7. The sample size for the training set:
* Not applicable. This is not an AI/ML device that requires a training set. If we consider the "training" for the device's design and manufacturing, it would be based on established engineering principles and safety standards, not a data training set.
8. How the ground truth for the training set was established:
* Not applicable for the same reasons as above.
{0}------------------------------------------------
K120235. 1/3
510(k) SUMMARY
Aerolase Model Nd:YAG 1064nm Laser
SEP 1 7 2012
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Aerolase Corporation/Aerolase Medical LLC (formerly Innotech USA, Inc.) 777 Old Saw Mill River Road, Suite 205 Tarrytown, NY 10591 Phone: (914) 345-8300 Facsimile: (914) 435-8303 Contact Person: Pavel Efremkin, Ph.D.
Date Prepared: September 7, 2012
Device Trade Names and Name/Address of Sponsor
Aerolase Model Nd: YAG 1064nm Laser: FriendlyLight Nd: YAG, FriendlyLight Neo ™ LiahtPod®ND:YAG™, LightPod® Neo™, LightPod® Forte™, LightPod® Allure™, LightPod® Nova™
Common or Usual Name
Nd:YAG Laser
Classification Name
Powered, Surgical Laser Instrument (21 C.F.R. §878.4810)
Predicate Devices
Innotech USA, , The FriendlyLight® Nd:YAG Lasers (K033251) Cutera, Inc., Cutera GenesisPlus Laser System (K103626) Incisive, Inc., PinPointe™ FootLaser" Nd:YAG Lasers (K093545, K093547) Fotona d.d., Fotona XP / Dynamis Nd:YAG Laser Systems (K090126, K101306)
Intended Use / Indications for Use
The Aerolase Nd:YAG Laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery, podiatry, and urology for surgical and aesthetic applications.
Dermatology:
The Aerolase Nd:YAG Laser is intended for the coagulation and hemostasis of benian vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte: and treatment of benian cutaneous lesions, such as warts, scars, striae, debridement of decubitus ulcer, treatment of keloids, and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to,
{1}------------------------------------------------
(λ623) 2/3
2/3
lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
Additionally, the Aerolase Nd:YAG Laser is indicated for 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 Aerolase Nd:YAG Laser is also indicated for the treatment of wrinkles, such as. but not limited to, periocular and perioral wrinkles.
The Aerolase Nd:YAG Laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Aerolase Nd:YAG Laser is also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The Aerolase Nd: YAG Laser is also indicated for the removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). Permanent hair reduction 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.
The Aerolase Nd:YAG Laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Podiatry:
Podiatry (ablation, vaporization, incision, excision, and coaqulation of soft tissue), including:
- . Matrixectomy:
- . Periungual and subungual warts:
- Plantar warts: ●
- Radical nail excision; ◆
- Neuromas. .
General Surgery:
The Aerolase Nd: YAG Laser is indicated for the incision/excision and cutting, ablation, coaqulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy gastroenterology, general surgery, head and neck/otolaryngology (ENT) neurosurgery, oculaplastics, orthopedics, plastic surgery, pulmonary/ thoracic surgery, gynecology (e.g. menorrhagia), podiatry and urology. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Technological Characteristics/Principles of Operation
{2}------------------------------------------------
120235 3/3
The Aerolase Nd:YAG 1064nm Laser is Neodynmium doped Yttriuim-Aluminum-Garnet ("Nd:YAG") Laser. This device consists of the following components and accessories: a power supply unit with an air-cooling system, and a laser hand piece connected to the power supply/air cooling system using umbilical cords. Laser parameters are controlled from a display panel located on the front of the power supply unit.
Performance Data
Product testing was performed to confirm compliance with the following standards: 21 C.F.R. 1040, IEC-60601-1, IEC-60601-2, IEC-60601-2-22, and IEC-60825-1. In all instances, the Aerolase 1064nm Laser functioned as intended and results observed were as expected. In addition, published clinical data supports the safe and effective use of this device.
Substantial Equivalence
The Aerolase Nd:YAG 1064nm Laser is as safe and effective as the identified predicate devices listed above. The Aerolase Nd: YAG 1064nm Laser has the same intended uses / indications for use, technological characteristics, and principles of operation as its predicate devices. Performance data demonstrate that the Aerolase Nd:YAG 1064nm Laser is as safe and effective as the predicate devices. Thus, the Aerolase Nd:YAG 1064nm Laser is substantially equivalent.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the logo.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 17 2012.
Aerolase Medical Lasers, LLC % Hogan Lovells US LLP Ms. Jennifer A. Henderson Regulatory Counsel 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
Re: K120235
Trade/Device Name: Aerolase Model Nd: YAG 1064nm Laser (Trade Names: FriendlyLight Nd: YAG, FriendlyLight Neo", LightPod®ND: YAG™ Tra: TAO, PricharyLight Ne0", Eight Od ND: FAG",
LightPod"Neo", LightPod"Forte"", LightPod" Allure", LightPod® Nova")
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: Class II Product Code: GEX Dated: September 13, 2012
Received: September 14, 2012
Dear Ms. Henderson:
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.
{4}------------------------------------------------
Page 2 - Ms. Jennifer A. Henderson
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For
Nef rlin 1.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use Statement
510(k) Number (if known): K120235
Device Name: Aerolase Model Nd: YAG 1064nm Laser (Trade Names: FriendlyLight Nd: YAG, FriendlyLight Neo™ , LightPod®ND:YAG™ , LightPod® Neo™ , LightPod® Forte™ , LightPod® Allure™ , LightPod® Nova™)
Indications for Use: -
The Aerolase Nd: YAG Laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic general surgery, gastroenterology, gynecology, otolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery, podiatry, and urology for surgical and aesthetic applications.
Dermatology:
The Aerolase Nd:YAG Laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte, and treatment of benign cutaneous lesions, such as warts, scars, striae, debridement of decubitus ulcer, treatment of keloids, and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
Additionally, the Aerolase Nd:YAG Laser is indicated for 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 Aerolase Nd: YAG Laser is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.
The Aerolase Nd:YAG Laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Aerolase Nd:YAG Laser is also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The Aerolase Nd:YAG Laser is also indicated for the removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). Permanent hair reduction 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.
The Aerolase Nd:YAG Laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Page 1 of 2
{6}------------------------------------------------
Podiatry:
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue), including:
- Matrixectomy; .
- Periungual and subungual warts; .
- Plantar warts; .
- Radical nail excision; ●
- Neuromas. .
General Surgery:
The Aerolase Nd: YAG Laser is indicated for the incision/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy gastroenterology, general surgery, head and neck/otolaryngology (ENT) neurosurgery, oculaplastics, orthopedics, plastic surgery; pulmonary/ thoracic surgery, gynecology (e.g. menorrhagia), podiatry and urology. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 2
Neil R. Dale for mtm
ision Sign-O (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120235
§ 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.