(87 days)
Cynosure PhotoGenica DL Laser, Altus Medical Aesthetic Nd:YAG Laser
Not Found
No
The summary describes a standard laser device with no mention of AI/ML, image processing, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is indicated for the "treatment of benign cutaneous vascular lesions and hair removal," which are therapeutic applications.
No
The device is indicated for treatment (cutaneous vascular lesions and hair removal), not for diagnosis.
No
The device description clearly indicates it is a physical laser system with significant weight and dimensions, requiring electrical power, and activated by physical switches. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of benign cutaneous vascular lesions and hair removal. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a laser that emits light to treat tissue. This is consistent with a therapeutic device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens. This device operates in vivo (on the body) for treatment.
N/A
Intended Use / Indications for Use
The Acclaim Dermatology Laser is indicated for benign vascular lesions and hair removal. The Cynosure Acclaim Dermatology Laser is indicated for the treatment of benign cutaneous vascular lesions and hair removal.
Product codes
GEX
Device Description
The Acclaim is a pulsed solid state laser, emitting at the near intra-red wavelength of 1064nm. Laser activation is both by finger switch and footswitch. Overall weight of the laser is 285lbs, and the size is 44"x19"x24" (HxWxD). Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cutaneous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
none
Description of the test set, sample size, data source, and annotation protocol
none
Summary of Performance Studies
none
Key Metrics
Not Found
Predicate Device(s)
Cynosure PhotoGenica DL Laser, Altus Medical Aesthetic Nd:YAG Laser.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP - 7 2001
Submitter:
Contact:
Date Summary Prepared:
Common Name:
Classification Name:
Device Trade Name:
Equivalent Device:
Device Description:
Intended Use:
Comparison:
Nonclinical Performance Data: Clinical Performance Data:
Conclusion:
Additional Information:
510(k) SUMMARY
- 0118 27
Cynsoure, Inc. 10 Elizabeth Drive Chelmsford, MA 01824
George Cho Senior Vice President of Medical Technology
June 11, 2001
Acclaim Dermatology Laser
Medical Laser System
Instrument, surgical, powered, laser 79-GEX 21 CFR 878.48
Cynosure PhotoGenica DL Laser and Altus Medical Aesthetic Nd:YAG Laser.
The Acclaim is a pulsed solid state laser, emitting at the near intra-red wavelength of 1064nm.
Laser activation is both by finger switch and footswitch. Overall weight of the laser is 285lbs, and the size is 44"x19"x24" (HxWxD).
Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.
The Acclaim Dermatology Laser is indicated for benign vascular lesions and hair removal.
The Acclaim Dermatology Laser has the same indication for uses, the same principle of operation, the same wavelength and pulse energy range as the predicate devices.
none
none
The Acclaim Dermatology Laser is another safe and effective device for dermatologic applications.
none
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 7 2001
Mr. George Cho Senior Vice President Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K011828
Trade/Device Name: Cynosure Acclaim Dermatology Laser Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II
Product Code: GEX Dated: June 11, 2001 Received: June 12, 2001
Dear Mr. Cho:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarrer ripps of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. George Cho
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 00911 o ditionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monmation on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or 1101) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Lis Walker, up
Image /page/2/Picture/5 description: The image contains a black and white drawing of a signature. The signature appears to be cursive and is written with a thick line. The signature is illegible, but it appears to be a stylized version of a name or word. The background of the image is white.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
501(k) Number (if known):
KO11828
Device Name:
Cynosure Acclaim Dermatology Laser
Indications For Use:
The Cynosure Acclaim Dermatology Laser is indicated for the treatment of benign cutaneous vascular lesions and hair removal.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division Sign-OII)
Division of General, Restorative
Division of General Devices Division of Genological Devices
510(k) Number K011828
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
(Optional Format 1-2-96)