(104 days)
755 nm:
The Cynosure Elite+ Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowting when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1064 nm:
The Cynosure Elite+ Laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae 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), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as 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.
Cynosure Elite+ laser has an Alexandrite crystal rod as the lasing medium, with a wavelength of 755 nm. The 1064 nm wavelength is generated from the Nd:YAG laser head.
Laser activation is by either by finger or foot switch. The overall weight of the laser is 180 lbs and the size is 41 x 15 x 25 in (HxWxD).
Electrical equipment is 208/240 VAC, single phase, 30A, 50/60 Hz.
The modifications to this device are four handpieces allowing for a larger treatment area; 18 mm, 20 mm, 22 mm and 24 mm. The 1064 Nd:YAG laser did not require any modifications to support the new handpieces. Minor modifications, including rod diameter change and lamp fill pressure change, were made to the Alexandrite laser to increase the energy to support the larger spot sizes. The software continues to control the energy based on the handpiece attached. This prevents the increase in available energy from the laser from increasing the fluence of the existing spot sizes.
This document is a 510(k) premarket notification for the Cynosure Elite+ Laser, seeking clearance for a modified device. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel clinical study data to prove the device meets specific acceptance criteria in a clinical setting.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning clinical performance metrics, cannot be fully extracted from this document in the way it would be for a direct clinical performance study.
However, based on the provided text, I can infer the acceptance criteria relate to the engineering and software performance specifications and that the study proving acceptance was non-clinical testing.
Here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from predicate device specifications) | Reported Device Performance (Elite+ K141425) |
|---|---|
| Laser Type: Alexandrite and Nd:YAG Lasers | Alexandrite and Nd:YAG Lasers |
| Wavelength: 755 nm & 1064 nm | 755 nm & 1064 nm |
| Maximum Fluence (755nm): 60 J/cm² | 60 J/cm² |
| Maximum Fluence (1064nm): 300 J/cm² | 300 J/cm² |
| Repetition Rate (755nm): 1 to 5 Hz | 1 to 5 Hz |
| Repetition Rate (1064nm): 1 to 10 Hz | 1 to 10 Hz |
| Pulse Duration: 0.1-300 ms | 0.1-300 ms |
| Spot Sizes (mm): (Predicate: 3, 5, 7, 10, 12.5, 15) | 3, 5, 7, 10, 12, 15, 18, 20, 22, 24 (The key modification) |
| Software Functionality: Meet software specifications | Testing confirmed that the software specifications were met. |
| Overall Performance: Device performs within the same specifications of the predicate device | Testing confirmed the performance of the Elite+ Laser meets the product system requirements, which is based on the predicate device. |
Important Note: The "acceptance criteria" here are engineering and operational parameters demonstrating equivalence to the predicate device, not clinical efficacy or safety endpoints for the expanded spot sizes. The document explicitly states "None" for clinical tests submitted.
The Study that Proves the Device Meets the Acceptance Criteria:
The document describes non-clinical tests as the study proving the device meets its performance requirements.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. As this was non-clinical engineering and software testing, the "sample size" would refer to the number of devices or test cycles, which is not detailed.
- Data Provenance: Not specified, but it would be internal testing conducted by Cynosure Incorporated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was non-clinical engineering and software testing. Ground truth was established by engineering specifications and direct measurement/validation against those specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this was non-clinical engineering and software testing. Adjudication methods are typically for human interpretation in clinical studies.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a laser system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical laser system, not an algorithm. The "standalone" performance here refers to the laser's physical and software operation, which was tested non-clinically.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the ground truth was based on engineering specifications, direct physical measurements, and software requirement validations.
8. The sample size for the training set:
- Not applicable. This device is a laser system, not an algorithm that requires a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable for the reason above.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2014
Cynosure Incorporated Ms. Kelli McMillan Regulatory Affairs Specialist 5 Carlisle Road Westford, Massachusetts 01886
Re: K141425 Trade/Device Name: Cynosure Elite+ Laser 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: August 11, 2014 Received: August 13, 2014
Dear Ms. McMillan:
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
{1}------------------------------------------------
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141425
Device Name Cynosure Elite+ Laser
Indications for Use (Describe)
755 nm:
The Cynosure Elite+ Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowting when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1064 nm:
The Cynosure Elite+ Laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae 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), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as 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.
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) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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510k Summary Elite+ Laser Special 510(k) K141425
| 807.92(a)(1) Submitter Information | |
|---|---|
| Applicant | Cynosure, Inc |
| Address | 5 Carlisle Road |
| Westford, MA 01886 | |
| Phone Number | (781) 993-2454 |
| Fax Number | (978) 256-6556 |
| Establishment Registration Number | 1222993 |
| Contact Person | Kelli McMillan |
| Preparation Date | September 10, 2014 |
| 807.92(a)(2) Name of Device | |
| Trade or Proprietary Name | Elite+ Laser |
| Common or Usual Name | Medical Laser System |
| Classification | II |
| Regulation Name | Laser Surgical Instrument for Use in General and Plastic Surgeryand in Dermatology |
| Classification Panel | General & Plastic Surgery |
| Regulation | 878.4810 |
| Product Code(s) | GEX |
| 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed | |
| Apogee Elite K034030 | |
| 807.92(2)(4) Device Description | |
| Cynosure Elite+ laser has an Alexandrite crystal rod as the lasingmedium, with a wavelength of 755 nm. The 1064 nm wavelengthis generated from the Nd:YAG laser head. | |
| Laser activation is by either by finger or foot switch. The overallweight of the laser is 180 lbs and the size is 41 x 15 x 25 in(HxWxD). | |
| Electrical equipment is 208/240 VAC, single phase, 30A, 50/60Hz. | |
| The modifications to this device are four handpieces allowingfor a larger treatment area; 18 mm, 20 mm, 22 mm and 24 mm.The 1064 Nd:YAG laser did not require any modifications tosupport the new handpieces. Minor modifications, includingrod diameter change and lamp fill pressure change, were madeto the Alexandrite laser to increase the energy to support thelarger spot sizes. The software continues to control the energybased on the handpiece attached. This prevents the increase inavailable energy from the laser from increasing the fluence ofthe existing spot sizes. | |
| 807/92(a)(5) Intended Use of the Device | |
| 755 nm:The Cynosure Elite+ Laser is indicated for stable long-term, orpermanent hair reduction. Permanent hair reduction is definedas long-term stable reduction in the number of hairs regrowing | |
| K141425 | |
| when measured 6, 9, or 12 months after the completion of atreatment regime. It is used for all skin types (Fitzpatrick I-VI)including tanned skin. It is also indicated for the treatment ofvascular lesions, benign pigmented lesions, and wrinkles. | |
| 1064 nm: | |
| The Cynosure Elite+ Laser is intended for the coagulation andhemostasis of benign vascular lesions such as, but not limited to,port wine stains, hemangiomas, warts, telangectasia, rosacea,venus lake, leg veins, spider veins and poikiloderma of civatte;and treatment of benign cutaneous lesions such as warts, scars,striae and psoriasis. The laser is also intended for the treatmentof benign pigmented lesions such as, but not limited to, lentigos(age spots), solar lentigos (sun spots), cafe au lait macules,seborrheic keratoses, nevi, chloasma, verrucae, skin tags,keratosis and plaques. | |
| The laser is also indicated for the treatment of wrinkles such as,but not limited to, periocular and perioral wrinkles. Additionally,the laser is indicated for the treatment of pseudofolliculitisbarbae (PFB) and for stable long-term, or permanent hairreduction. Permanent hair reduction is defined as long-termstable reduction in the number of hairs regrowing whenmeasured at 6, 9 and 12 months after the completion of atreatment regime. |
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510k Summary Elite+ Laser Special 510(k)
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510k Summary Elite+ Laser Special 510(k) K141425
| 807.92(a)(6) Summary of the Technological Characteristics of the Device compared to the Predicate | |||||
|---|---|---|---|---|---|
| Elite+K141425 | Apogee EliteK034030 | ||||
| Laser Type | Alexandrite and Nd:YAG Lasers | Alexandrite and Nd:YAG Lasers | |||
| Wavelength | 755 nm | 1064 nm | 755 nm | 1064 nm | |
| Maximum Fluence | 60 J/cm | 300 J/cm | 60 J/cm | 300 J/cm | |
| Repetition Rate | 1 to 5 Hz | 1 to 10 Hz | 1 to 5 Hz | 1 to 10 Hz | |
| Pulse Duration | 0.1-300 ms | 0.1-300 ms | |||
| Spot Sizes (mm) | 3, 5, 7, 10, 12, 15, 18, 20, 22, 24 | 3, 5, 7, 10, 12.5, 15 | |||
| 807.92(b)(1) Non-clinical tests submitted | |||||
| Test | Result | ||||
| Software | The testing confirmed that the software specifications were met. | ||||
| 807.92(b)(2) Clinical tests submitted | |||||
| None | |||||
| 807.92(b)(3) Conclusions drawn from non-clinical data | |||||
| Testing confirmed that the performance of the Elite+ Laser meets the product system requirements, which is based on the predicate device. | |||||
| Therefore, the modification resulted in a device that performs within the same specifications of the predicate device, and is therefore |
substantially equivalent.
§ 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.