(30 days)
Not Found
No
The summary describes a fiber optic accessory for a laser system and does not mention any AI or ML components or functionalities.
Yes
The device is described as an accessory to deliver optical energy for lasers used in surgical procedures like incision, excision, vaporization, ablation, coagulation of soft tissue, and laser-assisted lipolysis, which are therapeutic interventions.
No
The device is described as an accessory for surgical incision, excision, vaporization, ablation, and coagulation of soft tissue, and laser-assisted lipolysis. These are therapeutic, not diagnostic, functions.
No
The device is described as a "fiber optic accessory" and mentions "Performance (bench) testing summaries relating to the addition of the SideLaze800™ option," indicating it is a physical hardware component, not software.
Based on the provided information, the SideLaze800™ 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.
- SideLaze800™ Function: The SideLaze800™ is described as a fiber optic accessory that delivers optical energy from a laser for surgical procedures on soft tissue. It is used for incision, excision, vaporization, ablation, and coagulation of tissue, and laser-assisted lipolysis.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the body. The device directly interacts with the patient's tissue during a surgical procedure.
Therefore, the SideLaze800™ falls under the category of a surgical accessory used for therapeutic or surgical interventions, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
SideLaze800™ is an accessory to deliver optical energy for Cynosure 1440nm wavelength lasers and intended to be used with Cynosure 1440nm wavelength lasers' cleared indications for use, such as the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands) and laser assisted lipolysis. SideLaze800™ may be used in combination with a Cynosure SMA-compatible laser system for the same indications.
Product codes
GEX
Device Description
SideLaze800™ is an optional side-firing fiber optic accessory to the currently cleared Cynosure Lasers with 1440nm wavelength. The addition of the Cynosure SideLaze800™ option to the cleared laser devices is intended to offer physicians a convenient accessory within cleared indications for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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)
Performance (bench) testing summaries relating to the addition of the SideLaze800™ option is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K 121127
MAY 1 3 2012
510(k) Summary
.
| 510(K) Owner: | CYNOSURE, INC. |
|---|---|
| 5 Carlisle Road | |
| Westford, MA 01886 | |
| Telephone: 978-256-4200 | |
| Fax: 978 256 6556 | |
| Owner/Operator Number: 9006419 | |
| Contact: | Irina Kulinets |
| VP of Regulatory Affairs and Quality Systems | |
| CYNOSURE, INC. | |
| 5 Carlisle Road | |
| Westford, MA 01886 | |
| Telephone: 978-367-2350 | |
| Fax: 978 256 6556 | |
| Email: ikulinets@cynosure.com | |
| Submitter: | Lori Kahler |
| The RC Insight Group | |
| 461 Main Street, Suite 217 | |
| Pawtucket, RI 02860 | |
| Telephone: 202-715-6242 | |
| Fax: 202-686-2877 | |
| Email: lkahler@rcinsightgroup.com | |
| Manufacturer: | CYNOSURE, INC. |
| 5 Carlisle Road | |
| Westford, MA 01886 | |
| Telephone: 978-256-4200 | |
| Fax: 978-256-4200 | |
| Establishment Registration Number: 1222993 |
12 April 2012 Date Prepared:
Addition of SideLaze800™ Option -Special 510(k)
8
Confidential
1
Trade name: SideLaze800™, laser beam delivery accessory for Cynosure 1440nm wavelength lasers
Powered Laser Surgical Instrument (Laser Common name: for Surgery and Dermatology)
Classification name: 21 CFR 878.4810
GEX (Laser Surgical Instrument for Use in General and Plastic Product Code(s): Surgery and in Dermatology)
Classification: Class II
Predicate Devices (Claiming Substantial Equivalence):
Cynosure Multiwavelength Laser with 1440nm Wavelength K091537
Cynosure Cellulaze Laser and Cellulaze Delivery Kit K102541
Twister™ Side-Firing Optic Delivery System K12987
Summary Description of the Device:
SideLaze800™ is an optional side-firing fiber optic accessory to the currently cleared Cynosure Lasers with 1440nm wavelength. The addition of the Cynosure SideLaze800™ option to the cleared laser devices is intended to offer physicians a convenient accessory within cleared indications for use.
2
Intended Use / Indications for Use:
SideLaze800™ is an accessory to deliver optical energy for Cynosure 1440mm wavelength lasers and intended to be used with Cynosure 1440nm wavelength lasers' cleared indications for use, such as the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands) and laser assisted lipolysis. SideLaze800™ may be used in combination with a Cynosure SMA-compatible laser system for the same indications.
Technological Characteristics:
The SideLaze800™ option contains equivalent components and patient-contact materials as the cleared delivery accessories of Cynosure Multiwavelength Laser with 1440nm wavelength (K091537) and Cynosure Cellulaze (K102541). The fundamental scientific technology of the modified device (addition of SideLaze800™ accessory) has not changed.
Performance Standards:
This device conforms to the Laser Performance Standard (21 CFR 1040). No additional performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
Performance Data:
Performance (bench) testing summaries relating to the addition of the SideLaze800™ option is included in this submission.
Substantial Equivalence:
The SideLaze800™ option of the Cynosure 1440nm wavelength lasers is as safe and effective as the accessories cleared with the Cynosure Multiwavelength Lasers with 1440nm wavelength. The SideLaze800™ accessory option does not represent any fundamental changes in technology or any changes in indicated use, and this accessory option does not raise any additional questions of safety and effectiveness. In summary, the addition of the SideLaze800™ option used to deliver optical energy for Cynosure 1440nm wavelength lasers described in this submission is substantially equivalent to the predicate devices.
Confidential
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cynosure, Inc. % Ms. Irina Kulinets Vice President, Regulatory Affairs and Quality Systems 5 Carlisle Road Westford, Massachusetts 01886
MAY 1 3 2012
Re: K121127
Trade/Device Name: SideLaze800", Laser Beam Delivery Accessory for Cynosure 1440nm Wavelength Lasers
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
plastic surgery and in dermatolo
. Class II
Regulatory Class: Class II Product Code: GEX Dated: May 08, 2012 Received: May 10, 2012
Dear Ms. Kulinets:
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. Irina Kulinets
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 vours.
For Robert chriſtopher Dri
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
K,121127
510(k) Number (if known):
Device Name:
SideLaze800™, laser beam delivery accessory for Cynosure 1440nm wavelength lasers
Indications for Use:
SideLaze800™ is an accessory to deliver optical energy for Cynosure 1440nm wavelength lasers and intended to be used with Cynosure 1440nm wavelength lasers' cleared indications for use, such as the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands) and laser assisted lipolysis. SideLaze800™ may be used in combination with a Cynosure SMA-compatible laser system for the same indications.
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) | Neil RP Ogden for mxn |
|---|---|
| (Division Sign-Off) | |
| Division of Surgical, Orthopedic, and Restorative Devices |
| Addition of SideLaze800™ Option - Special 510(k) | Confidential | Page 6 of 18 |
|---|---|---|
| -------------------------------------------------- | -------------- | -------------- |
| 510(k) Number | K121127 |
|---|---|
| --------------- | --------- |