(27 days)
Not Found
Not Found
No
The summary describes a laser system with a smoke evacuator and does not mention any AI or ML components or functionalities.
Yes
The device is intended for "coagulation, vaporization, ablation or cutting of soft tissue (skin)" which are therapeutic actions.
No
The device is described as an Er:Y AG Laser System intended for coagulation, vaporization, ablation, or cutting of soft tissue, which are therapeutic actions, not diagnostic ones. There is no mention of it being used to detect, diagnose, or monitor a disease or condition.
No
The device description clearly outlines a physical laser system with hardware components like an articulated arm, handpiece, foot switch, and a smoke evacuator. It also provides physical specifications like weight and dimensions. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is an Er: Y AG laser system intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin). This is a direct treatment or surgical procedure performed on the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use describes surgical procedures on skin and surrounding areas, not diagnostic testing of biological samples.
- Device Description: The description details a laser system with an articulated arm and handpiece, consistent with a surgical or therapeutic device, not a diagnostic instrument.
Therefore, the MCL 30 Dermablate Er: Y AG Laser System is a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).
The smoke evacuator integrated into the handpiece is intended to remove aerosol, a by-product of laser treatment.
Product codes (comma separated list FDA assigned to the subject device)
79-GEX
Device Description
MCL 30 Dermablate Er: Y AG Laser System is an Er: Y AG laser system, having an articulated arm and handpiece. It is a laser with a wavelength of approximately 2.94 um. Laser emission activation is by foot switch. Overall weight of the laser is 85 kg, and the size is 970x360x650 cm (HxWxD). Electrical requirement is 230 VAC, 16A, 50-60 Hz, single phase. Smoke evacuation is provided by the evacuator integrated into the handpiece that removes the aerosol, a by-product of laser treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (skin)
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)
Nonclinical Performance Data: none Clinical Performance Data: none
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.
DermaStar Er:Y AG Laser System
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
NOV 2 4 2004
510(K) Summary
KO42967 Cynosure, Inc. Submitter: 10 Elizabeth Drive Chelmsford, MA 01824 George Cho Contact: Senior Vice President of Medical Technology October 25, 2004 Date Summary Prepared: MCL 30 Dermablate Er: Y AG Laser System Device Trade Name: MCL 30 Dermablate Common Name: Instrument, surgical, powered, laser Classification Name: 79-GEX 21 CFR 878.48 Equivalent Device: DermaStar Er:Y AG Laser System MCL 30 Dermablate Er: Y AG Laser System is an Er: Y AG laser Device Description: system, having an articulated arm and handpiece. It is a laser with a wavelength of approximately 2.94 um. Laser emission activation is by foot switch. Overall weight of the laser is 85 kg, and the size is 970x360x650 cm (HxWxD). Electrical requirement is 230 VAC, 16A, 50-60 Hz, single phase. Smoke evacuation is provided by the evacuator integrated into the handpiece that removes the aerosol, a by-product of laser treatment. Intended Use: Intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes). Comparison: The MCL 30 Dermablate Er: Y AG Laser System is substantially equivalent to the DermaStar Er: YAG Laser System, with the same principle of operation, the same wavelength and essentially the same power range as the predicate device for the same indications for uses. Nonclinical Performance Data: none Clinical Performance Data: none Conclusion: The MCL 30 Dermablate Er: Y AG Laser System is another safe and effective device for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes). Additional Information: nonc
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2004
Asclepion Laser Technologies GmbH c/o Mr. George Cho Senior Vice President, Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K042968
Trade/Device Name: MCL 30 Dermablate Er: 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: II Product Code: GEX Dated: October 25, 2004 Received: October 28, 2004
Dear Mr. Cho:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. George Cho
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Millken
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
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: MCL 30 Dermablate Er:Y AG Laser System
Indications For Use:
Intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).
The smoke evacuator integrated into the handpiece is intended to remove aerosol, a by-product of laser treatment.
Prescription Use
(Part 21 CFR 801 Subpart D)
✓
OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millkeisen
al. Restorative, Division of Ge and Neurological Devices
510(k) Number K042968