(134 days)
Not Found
No
The provided text describes a laser system for soft tissue procedures and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
Explanation: The device is described for procedures like 'Incision, Excision, Ablation, Vaporization of Soft Tissue' and treatments for 'Tattoo Removal', 'Dermal Pigmented Lesions', 'Skin Resurfacing for Acne Scars and Wrinkles', and 'Vascular lesions', all of which are medical treatments aimed at improving a patient's health or condition.
No
The provided text describes a laser system intended for the incision, excision, ablation, vaporization, and coagulation of soft tissue, as well as for treating various skin conditions like tattoo removal, pigmented lesions, and scars. These are all therapeutic or surgical procedures, not diagnostic ones. The device's function is to modify tissue, not to identify or characterize disease.
No
The device description explicitly states it is a "Laser System" consisting of a console, articulated arm, handpiece adaptor, and handpieces, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The description clearly states that this device is a laser system used for direct treatment of soft tissue through incision, excision, ablation, and vaporization. It also mentions applications like tattoo removal, treatment of pigmented and vascular lesions, skin resurfacing, and scar reduction. These are all therapeutic procedures performed directly on the patient's body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any specimens derived from the human body. Its function is to deliver energy to the tissue itself.
Therefore, the intended use and device description align with a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis
Specific Indications:
1064 nm wavelength
- . Tattoo Removal (dark ink: blue and black)
- Dermal Pigmented Lesions; including, but not limited to: Nevus of Ota, Lentigines, Nevi, . Melasma and Cafe-au-lait
- Removal or lightening of hair with or without adjuvant preparation. .
- . Skin Resurfacing for Acne Scars and Wrinkles
- Benign cutaneous lesions; including, but not limited to: striae and scars (excludes the 650nm . wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral . part of the scar (excludes the 650nm wavelength)
532 nm Wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional Multilite Dyc Laser Handpiece)
- Tattoo removal (light ink: red, sky blue, green) .
- Vascular Iesions including but not limited to: port wine birthmarks, telangiectasias, spider . angioma, cherry angioma, spider nevi
- Epidermal Pigmented lesions; including, but not limited to: cafe-au-lait birthmarks, solar . lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus, seborrheic keratosis
- Skin Resurfacing for Acne Scars and Wrinkles .
- Benign cutaneous lesions; including, but not limited to: striae and scars, (excludes the 650nm . wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral . part of the scar (excludes the 650nm wavelength)
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The RevLite Q-Switched Nd: YAG Laser System consist of an electrically powered Console, in which laser energy produced within the system is delivered to the tissues by means of an articulated arm, Handpiece Adaptor and specially designed handpieces. The user ectivates laser emission by means of a footswitch.
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
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
.
·
510(k) Summary for RevLite Q-Switched Nd: YAG Laser System
A. Sponsor
Cynosure, Inc. 5 Carlisle Road Westford, MA 01886
B. Contact
C. Device Name
| Trade Name: | RevLite Q-Switched Nd: YAG Laser System |
|---|---|
| Common/usual Name: | Medical Laser System |
| Classification Name: | GEX-Powered laser surgical instrument, General & Plastic Surgery |
| 21 CFR 878.4810, Class II |
D. Predicate Device
| Trade Name: | RevLite Q-Switched Nd:YAG Laser System |
|---|---|
| Common/usual Name: | Dermatology Laser System |
| Classification Name: | GEX-Powered laser surgical instrument, General & Plastic Surgery |
| 21 CFR 878.4810, Class II | |
| Premarket Notification: | HOYA PHOTONICS, Inc., K103118 (11/19/2010) |
| Trade Name: | SPECTRA Q-Switched Nd:YAG |
| Common/usual Name: | Laser System with Dye Handpieces |
| Classification Name: | GEX-Powered laser surgical instrument, General & Plastic Surgery |
| 21 CFR 878.4810, Class II | |
| Premarket Notification: | Lutronic Corporation, K113588 (2/2/2012) |
| Trade Name: | Palomar Q-YAG 5TM Nd:YAG Laser System |
| Common/usual Name: | Q: Switched Nd: YAG |
| Classification Name: | GEX-Powered laser surgical instrument, General & Plastic Surgery |
| 21 CFR 878.4810, Class II | |
| Premarket Notification: | Palomar Medical Technologies, Inc., K061436 (12/06/2006) |
E. Device Description
The RevLite Q-Switched Nd: YAG Laser System consist of an electrically powered Console, in which laser energy produced within the system is delivered to the tissues by means of an articulated arm, Handpiece Adaptor and specially designed handpieces. The user ectivates laser emission by means of a footswitch.
F. Intended Use
1
Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
Specific Indications:
1064 nm wavelength
- . Tattoo Removal (dark ink: blue and black)
- Dermal Pigmented Lesions; including, but not limited to: Nevus of Ota, Lentigines, Nevi, . Melasma and Cafe-au-lait
- Removal or lightening of hair with or without adjuvant preparation. .
- . Skin Resurfacing for Acne Scars and Wrinkles
- Benign cutaneous lesions; including, but not limited to: striae and scars (excludes the 650nm . wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral . part of the scar (excludes the 650nm wavelength)
532 nm Wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional Multilite Dyc Laser Handpiece)
- Tattoo removal (light ink: red, sky blue, green) .
- Vascular Iesions including but not limited to: port wine birthmarks, telangiectasias, spider . angioma, cherry angioma, spider nevi
- Epidermal Pigmented lesions; including, but not limited to: cafe-au-lait birthmarks, solar . lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus, seborrheic keratosis
- Skin Resurfacing for Acne Scars and Wrinkles .
- Benign cutaneous lesions; including, but not limited to: striae and scars, (excludes the 650nm . wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral . part of the scar (excludes the 650nm wavelength)
The RevLite Q-Switched Nd: YAG Laser System (K103118) is currently indicated for the treatment of Dermal Pigmented lesions (1064 nm wavelength) and Epidermal Pigmentation lesions (532 nm wavelength). Both dermal and cpidermal pigmented lesions are types of benign pigmented lesions. Cynosure is seeking to clarify the indications for use statement for RevLite Q Switched laser to include examples of other pigmented lesions. There have been no changes to the device and the submission is only related to clarification of pigmented lesions.
G. Technological Characteristics
The laser systems have the same technological characteristics. All of the devices are Q-switched Nd: Y AG lasers operating at wavelengths of 1064 nm and 532 nm. Additionally, dye handpieces are available that convert the 532 nm wavelength beam into 585 nm or 650 nm wavelengths. The RevLite Q Switched Laser System has the exact same technological characteristics as the previously cleared RevLite Q Switched Laser System (K 103118). The clarified RevLite Indications for Use statement has the same example of benign cutaneous lesions, vascular lesions and epidermal pigmented treated as the RevLite, Spectra and Palomar predicates.
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| Proposed Device | Predicate Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| 510(k)# | K103118 | K113588 | K061436 | |
| Manufacturer | Cynosure (HOYA ConBio) | Cynosure (HOYA ConBio) | Lutronic Corporation | Palomar Medical |
| Technologies, Inc. | ||||
| Device Name | RevLite Q-Switched | |||
| Nd: YAG Laser System | RevLite Q-Switched | |||
| Nd: YAG Laser System | Spectra Q-Switched Nd: YAG | |||
| Laser system | Q-YAG 5 Nd: YAG laser | |||
| system | ||||
| Clearance Date | 11/19/2010 | 2/22/2012 | 12/6/2006 | |
| Classification/ Regulation | 21 CFR 878.4810 (GEX) | 21 CFR 878.4810 (GEX) | 21 CFR 878.4810 (GEX) | 21 CFR 878.4810 (GEX) |
| Laser Medium | Nd: YAG | Nd: YAG | Nd: YAG | Nd: YAG |
| Operating Parameters | Q-Switched | Q-Switched | Q-Switched | Q-Switched |
| Wavelength | 1064nm / 532 nm | 1064nm / 532 nm | 1064nm / 532 nm | 1064nm / 532 nm |
| Pulse Characteristics: | ||||
| Maximum Pulse Duration | 7 - 20 ns | 7 - 20 ns | 5 - 10 ns | 3 ns |
| Energy Delivered | 1.6 J | 1.6 J | 1.2 J | 0.4 J |
| Fluence | 1 - 8 J/cm2 @ 3 - 8 mm spot | |||
| size | 1 - 8 J/cm2 @ 3 - 8 mm spot | |||
| size | 5 - 10 J/cm2 | 3.45 J/cm2 @ 4 mm spot size | ||
| Spot Sizes | 2-8.5mm range with 0.1mm | |||
| increments | 2-8.5mm range with 0.1mm | |||
| increments | 3,4,5,6,7,8 mm / 1,2,3,4,5,6,7 | |||
| mm (option) | 2 mm, 4 mm, 6 mm | |||
| (optional) | ||||
| Repetition Rate | Single shot, 1,2,5, 10 Hz | Single shot, 1,2,5, 10 Hz | Max. 10 Hz | 1-10 Hz |
| Physical Characteristics: | ||||
| System Dimensions | 31.8" (H) x 12" (W) x 28.5" | |||
| (D) | 31.8" (H) x 12" (W) x 28.5" | |||
| (D) | 11.6" (W) x 25.8" (L) x | |||
| 66.93" (H) | 18" (L) x 19" (H) x 17" (D) | |||
| System Weight | 131 lbs. | 131 lbs. | 194 lbs. | 88 lbs. |
| Electrical Requirements | AC 230 V, 50/60 Hz | AC 230 V, 50/60 Hz | AC 220-230V, 50/60 Hz | 100 - 240 V, 50/60 Hz |
| Maximum Power | 20W | 20W | 240MW | 4W |
:
・
ﺑ
Indications for Use Statement
3
| Proposed Device | Predicate Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| 1064 nm wavelength | 1064 nm wavelength | 1064 nm Wavelength | 1064 nm Wavelength | |
| Tattoo Removal (dark ink: | ||||
| blue and black) | Tattoo Removal (dark ink: | |||
| blue and black) | Tattoo removal: dark ink | |||
| (black, blue and brown) | Indicated for skin resurfacing | |||
| with or without adjuvant | ||||
| Dermal Pigmented Lesions; | Dermal Pigmented Lesions | Removal of Nevus of Ota | preparation, dark ink tattoo | |
| including, but not limited to: | Nevus of Ota | Removal or lightening of | removal (e.g., black ink), | |
| Nevus of Ota, Lentigines, | Removal or lightening of hair | unwanted hair with or | removal of pigmented | |
| Nevi, Melasma and Cafe-au- | with or without adjuvant | without adjuvant preparation. | lesions, including, but not | |
| lait | preparation. | Treatment of Common Nevi | limited to, lentigines, nevi, | |
| Removal or lightening of | Skin Resurfacing for Acne | Skin resurfacing procedures | melasma, and cafe-au-lait, | |
| hair with or without adjuvant | Scars and Wrinkles | for the treatment of acne | and the removal or lightening | |
| preparation. | Benign cutaneous lesions, | scars and wrinkle | of hair. | |
| Skin Resurfacing for Acne | such as, but not limited to: | Treatment of melasma | ||
| Scars and Wrinkles | striae and scars | 532 nm Wavelength | ||
| Benign cutaneous lesions; | excludes the 650nm | 532nm Wavelength (nominal | Indicated for the removal of | |
| Intended Use / Indications for | ||||
| Use | including, but not limited to: | wavelength) | delivered energy of 585 nm | red ink tattoos, treatment of |
| striae and scars (excludes the | Reduction of red | and 650 nm with optional | vascular lesions, including | |
| 650nm wavelength) | pigmentation in hypertrophic | dye handpieces): | facial and leg veins, | |
| Reduction of red | and keloid scars where | Tattoo removal: light ink | telangiectasias, angiomas, | |
| pigmentation in hypertrophic | vascularity is an integral part | (red, tan, purple, orange, sky | hemangiomas, portwine | |
| and keloid scars where | of the scar (excludes the | blue, green) | stains, and most pigmented | |
| vascularity is an integral part | 650nm wavelength) | Removal of Epidermal | lesions (e.g., lentigines, | |
| of the scar (excludes the | Pigmented Lesions | ephelides). The 1064/532 nm | ||
| 650nm wavelength) | 532 nm wavelength (nominal | Removal of Minor Vascular | blended wavelength is | |
| delivered energy of 585 nm | Lesions including but not | indicated for tattoo removal. | ||
| 532 nm wavelength (nominal | and 650 nm with the | limited to telangiectasias | ||
| delivered energy of 585 nm | Optional Multilite Dye Laser | Treatment of Lentigines | ||
| and 650 nm with the | Handpiece) | Treatment of Cafe-Au-lait | ||
| Optional Multilite Dye Laser | Tattoo removal (light ink: red, | Treatment of Seborrheic | ||
| Handpiece) | sky blue, green) | Keratoses | ||
| Tattoo removal (light ink: | Vascular lesions including but | Treatment of Post | ||
| red, sky blue, green) | not limited to: port wine | Inflammatory Hyper | ||
| Vascular lesions including | birthmarks, telangiectasias, | Pigmentation | ||
| but not limited to: port wine | spider angioma, cherry | Treatment of Becker's Nevi, |
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Indications for Use Statement
| Proposed Device | Predicate Device | Predicate Device | Predicate Device |
|---|---|---|---|
| birthmarks, telangiectasias, | |||
| spider angioma, cherry | |||
| angioma, spider nevi | |||
| Epidermal Pigmented | |||
| lesions; including, but not | |||
| limited to: cafe-au-lait | |||
| birthmarks, solar lentiginos, | |||
| senile lentiginos, Becker's | |||
| nevi, Freckles, Nevus spilus, | |||
| seborrheic keratosis | |||
| Skin Resurfacing for Acne | |||
| Scars and Wrinkles | |||
| Benign cutaneous lesions; | |||
| including, but not limited to: | |||
| striae and scars (excludes the | |||
| 650nm wavelength) | |||
| Reduction of red | |||
| pigmentation in hypertrophic | |||
| and keloid scars where | |||
| vascularity is an integral part | |||
| of the scar (excludes the | |||
| 650nm wavelength) | angioma, spider nevi | ||
| Epidermal Pigmented lesions | |||
| including but not limited to: | |||
| cafe-au-lait birthmarks, solar | |||
| lentiginos, senile lentiginos, | |||
| Becker's nevi, Freckles, | |||
| Nevus spilus | |||
| Skin Resurfacing for Acne | |||
| Scars and Wrinkles | |||
| Benign cutaneous lesions, | |||
| such as, but not limited to: | |||
| striae and scars (excludes the | |||
| 650nm wavelength) | |||
| Reduction of red | |||
| pigmentation in hypertrophic | |||
| and keloid scars where | |||
| vascularity is an integral part | |||
| of the scar (excludes the | |||
| 650nm wavelength) | Freckles and Nevi Spilus |
.
. . . . .
.
:
5
H. Substantial Equivalence
Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated $10(k)s", the proposed device, RevLite Q-Switched Nd:YAG Laser System is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance characteristics. The RevLite Q-Switched Nd:YAG Laser System is as safe, as effective, and performs as well as the predicate devices.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/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 representation of three overlapping human figures.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2014
Cynosure Incorporated Mrs. Huda Yusuf, MSc. Senior Regulatory Affairs Specialist 5 Carlisle Road Westford, Massachusetts 01888
Re: K133254
Trade/Device Name: RevLife O-Switched Nd:YAG Laser System 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: December 4, 2013 Received: December 5, 2013
Dear Mrs. Yusuf:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
7
Page 2 - Mr. Huda Yusuf, MSc.
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aguel
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use Statement
| 510(k) number | K133254 |
|---|---|
| Device Name | RevLite Q-Switched Nd:YAG Laser System |
| Intended Use | Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, |
| Dermatologic and General Surgical Procedures for Coagulation and Hemostasis | |
| Specific Indications | 1064 nm wavelength Tattoo Removal (dark ink: blue and black) Dermal Pigmented Lesions; including, but not limited to: Nevus of Ota, Lentigines, |
| Nevi, Melasma and Cafe-au-lait Removal or lightening of hair with or without adjuvant preparation. Skin Resurfacing for Acne Scars and Wrinkles Benign cutaneous lesions; including, but not limited to: striae and scars (excludes | |
| the 650nm wavelength) Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is | |
| an integral part of the scar (excludes the 650nm wavelength) 532 nm Wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional | |
| Multilite Dye Laser Handpiece) Tattoo removal (light ink: red, sky blue, green) Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, | |
| spider angioma, cherry angioma, spider nevi Epidermal Pigmented lesions; including, but not limited to: cafe-au-lait birthmarks, | |
| solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus, seborrheic | |
| keratosis Skin Resurfacing for Acne Scars and Wrinkles Benign cutaneous lesions; including, but not limited to: striae and scars, (excludes | |
| the 650nm wavelength) Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is | |
| an integral part of the scar (excludes the 650nm wavelength) | |
| Prescription Use | |
| (Part 21 CFR 801 Subpart D) | Over-The-Counter Use |
| AND/OR | |
| (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)
Felipe Aguel Date: 2014.03.05
11:44:57 -05'00'
(Division Sign-Off) for BSA Division of Surgical Devices 510(k) Number K133254