(54 days)
Not Found
No
The summary describes a laser device with preset modes and adjustable parameters, but there is no mention of AI or ML technology being used for decision-making, parameter adjustment, or any other function.
No
The device is described as a "surgical device" and is intended for "hair reduction", which is considered a cosmetic purpose rather than a therapeutic one. While "therapeutic" is mentioned in one of the standards the device complies with (IEC 60601-2-2:2007 for "Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment"), the primary indicated use is hair reduction, not treatment of a disease or medical condition.
No
Explanation: The device is intended for hair reduction, which is a therapeutic/cosmetic purpose, not diagnosis. While one of the cited standards (IEC 60601-2-2:2007) mentions "diagnostic laser equipment," the intended use and device description clearly state its function as hair reduction, not diagnosis.
No
The device description explicitly lists hardware components such as a Handpiece, Emergency Switch, Key Switch, Connector, Indicator Lamp, and Foot Switch, and refers to it as a "surgical device."
Based on the provided information, the New Era Laser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for hair reduction on the human body. This is a physical treatment applied directly to the patient.
- Device Description: The device is described as a "surgical device" and its components are related to delivering laser energy to the skin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to treat the body directly. The New Era Laser is a therapeutic device.
N/A
Intended Use / Indications for Use
The New Era Laser is intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The proposed device, New Era, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
There is one model, FG 2000.
Table 1 Specifications
Model: FG 2000-D
Size: 5959146 cm
Weight: 45kg
Handpiece: Refer to Fig 16
Cooler Number: 1
The main components of proposed device shown as following:
Table 2 Main Components of Proposed Device
Components:
Handpiece - Deliver the laser to area to be treated
Emergency Switch - Stop the system in case of emergency situation
Key Switch - Start the system
Connector - Connection of the device with the handpiece
Indicator Lamp - Indicate current working state of the appliance
Foot Switch - Activate the laser emission
The proposed system provides 36 working modes, which are six modes for men and six modes for women, the men or women mode includes Parameter one, two, three, four, five and six mode respectively for different preset parameter combination, and each particular parameter preset mode includes three submode as mode 1, mode 2 and mode 3.
The difference for each mode is only the default parameter, but all parameters for each mode can be adjustable in the parameter range.
The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black);
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
No clinical study is included in this submission.
Description of the test set, sample size, data source, and annotation protocol
No clinical study is included in this submission.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
IEC 60601-2-2:2007, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment;
IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1
Performance Testing for Spot Size Accuracy and Energy Output Accuracy.
No clinical study is included in this submission.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font in blue.
November 14, 2018
Step Up Skin Laser, LLC % Irving Wiesen Official Correspondent Law Offices of Irving L. Wiesen, P.C. 420 Lexington Avenue Suite 2400 New York, New York 10170
Re: K182604
Trade/Device Name: New Era 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: September 20, 2018 Received: September 21, 2018
Dear Irving Wiesen:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Neil R.P. Neil R.P. Ogden Date: 2018.11.14 Ogden 16:24:31 -05'00'
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name New Era Laser
Indications for Use (Describe)
The New Era Laser is intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Tab #7 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number:
- Date of Preparation
September 6, 2018
- Sponsor
Step Up Skin Laser LLC 433 5th Ave, 6th floor , New York, NY 10016
Contact person: Michelle Hokama President michellehokama911@gmail.com cell number :347-642-2982 company: 646-577-3333 , 646-882-8479
Establishment Registration Number: Not yet registered
- Submission Correspondent
Irving L. Wiesen, Esq. Law Offices of Irving L. Wiesen, P.C. 420 Lexington Avenue - Suite 2400 New York, New York 10170 Tel. 212-381-8774 Fax 646-536-3185 Email: iwiesen@wiesenlaw.com Website: www.wiesenlaw.com
4
4. Identification of Proposed Device
Trade Name: New Era
Common Name: Powered Laser Surgical Instrument
Regulatory Information: Classification Name: Powered Laser Surgical Instrument
Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery
Intended Use:
The New Era is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the 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.
5. Device Description
The proposed device, New Era, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
There is one model, FG 2000.
Table 1 Specifications
| Model | FG 2000-D |
|---|---|
| Size | 5959146 cm |
| Weight | 45kg |
| Handpiece | Refer to Fig 16 |
| Cooler Number | 1 |
The main components of proposed device shown as following: Table 2 Main Components of Proposed Device
| Components | Function Description | Applic |
|---|---|---|
| Handpiece | Deliver the laser to area to be treated | FG 2 |
d Model(s) 000
5
| Emergency
| Switch | Stop the system in case of emergency situation | FG 2000 |
|---|---|---|
| Key Switch | Start the system | FG 2000 |
| Connector | Connection of the device with the handpiece | FG 2000 |
| Indicator Lamp | Indicate current working state of the appliance | FG 2000 |
| Foot Switch | Activate the laser emission | FG 2000 |
The proposed system provides 36 working modes, which are six modes for men and six modes for women, the men or women mode includes Parameter one, two, three, four, five and six mode respectively for different preset parameter combination, and each particular parameter preset mode includes three submode as mode 1, mode 2 and mode 3.
The difference for each mode is only the default parameter, but all parameters for each mode can be adjustable in the parameter range.
The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black);
- Identification of Predicate Device
Predicate K161692 Diode Laser Therapy Machine Model FG2000D
Beijing ADSS Development Co., Ltd.
- Non-Clinical Test Conclusion
The proposed device, New Era, Model FG2000, is identical in all respects to the predicate device.
6
It is made by the same manufacturer, utilizing the same controls, components, and processes of the predicate device.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
IEC 60601-2-2:2007, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment;
IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1
Performance Testing for Spot Size Accuracy and Energy Output Accuracy.
Clinical Test Conclusion 8.
No clinical study is included in this submission.
9. Substantially Equivalent (SE) Comparison
| 21 CF | |
|---|---|
| nded for | The Diode 1 |
| nent | Removal Sy |
| skin | for hair ren |
| type | permanent |
| skin. | on all ski |
| tion is | (Fitzpatrick |
| 1, stable | VI), includi |
| ber of | Permanent |
| measured | is defined as |
| after the | stable reduc |
| eatment | number of |
| when measu | |
| months afte: | |
| of a trea |
7
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | GEX | GEX |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Intended Use | The New Era is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the 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. | The Diode Laser Hair Removal System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the 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. |
Configuration Main Unit
Main Unit
8
| Handpiece | Handpiece | Handpiece | SE | |
|---|---|---|---|---|
| Foot Control | Foot Control | Foot Control | SE | |
| Principle of | ||||
| Operation | Diode Laser | Diode Laser | Diode Laser | SE |
Table 4 Performance Comparison
| Item | Proposed Device | Predicate | Remark |
|---|---|---|---|
| Laser Type | Diode Laser | Diode Laser | SE |
| Laser Classification | Class IV | Class IV | SE |
| Laser Wavelength | 808 nm | 808 nm | SE |
| Spot Size | 1.44 cm2 | 1.44 cm2 | SE |
| Fluence | 2-120J/ cm2 | 2-120J/cm2 | SE |
9
| Frequency | 1-10Hz | 1-10Hz | SE |
|---|---|---|---|
| Pulse Duration | 9-143ms | 9-143ms | SE |
| Power Supply | AC 110V/50Hz-60Hz | AC110V/50Hz-60Hz | SE |
| Dimension | 5959146cm | 5959146cm | SE |
| Weight | 49g kg | 49g | SE |
Discussion
The proposed device, New Era, Model FG2000, is identical in all respects to the predicate device. It is made by the same manufacturer, utilizing the same controls, components, and processes of the predicate device.
Table 5 Safety Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Patient Contact Materials and Biocompatibility | |||
| Patient | |||
| Contact | Sapphire in handpiece and | ||
| handpiece tip | Sapphire in handpiece and | ||
| handpiece tip | SE | ||
| Materials | (Stainless Steel) | (Stainless Steel) | |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity; no evidence of | |
| sensitization or irritation | |||
| Sensitization | No evidence of | ||
| sensitization | SE | ||
| Irritation | No evidence of irritation | ||
| EMC, Electrical and Laser Safety | |||
| Electrical | |||
| Safety | Comply with IEC 60601-1, | ||
| IEC |
60601-2-22 | Comply with IEC 60601-1, IEC
60601-2-22 | SE |
10
| EMC | Comply with IEC 60601-1-
2 | Comply with IEC 60601-1-2 | SE |
|--------------|---------------------------------------|---------------------------------------|----|
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | SE |
10. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.