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.

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.

The main components of proposed device shown as following: Handpiece, Emergency Switch, Key Switch, Connector, Indicator Lamp, Foot Switch.

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);

AI/ML Overview

The provided FDA 510(k) premarket notification for the "New Era" laser device aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for a novel medical function. Therefore, the typical structure for reporting acceptance criteria and a study proving those criteria (as requested in the prompt) does not directly apply to this document.

The document primarily focuses on showing that the "New Era" laser is identical in all respects to an already cleared predicate device (K161692 Diode Laser Therapy Machine Model FG2000D). This means the "acceptance criteria" here are essentially proof of sameness to the predicate.

However, based on the information provided, I can construct a response that addresses the spirit of your request by interpreting the "acceptance criteria" as the shared specifications and safety standards that both the proposed and predicate devices meet, and the "study" as the non-clinical testing performed to show this equivalence.

Here's a breakdown of the requested information based on the provided text:

Key Takeaway: No independent clinical study data proving specific performance outcomes for the "New Era" laser is presented in this 510(k) submission. The entire premise is based on the device being identical to an already cleared predicate device, and thus inheriting its established safety and performance profile.

Acceptance Criteria and Device (Equivalence) Performance:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of traditional performance metrics like sensitivity/specificity for a diagnostic AI, the "acceptance criteria" for a 510(k) based on substantial equivalence revolve around matching the predicate device's specifications, intended use, and safety standards.

Acceptance Criteria (Based on Predicate Device Equivalence)	Reported Device Performance ("New Era" Laser)
Intended Use Equivalence: - Hair removal - Permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. - Permanent hair reduction defined as long-term, stable reduction in hair regrowth at 6, 9, and 12 months post-treatment.	Identical. The New Era Laser is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Definition of permanent hair reduction is identical.
Product Code Equivalence: GEX	Identical. GEX
Regulation Number Equivalence: 21 CFR 878.4810	Identical. 21 CFR 878.4810
Configuration Equivalence: Main Unit, Handpiece, Foot Control	Identical. Main Unit, Handpiece, Foot Control
Principle of Operation Equivalence: Diode Laser	Identical. Diode Laser
Laser Type Equivalence: Diode Laser	Identical. Diode Laser
Laser Classification Equivalence: Class IV	Identical. Class IV
Laser Wavelength Equivalence: 808 nm	Identical. 808 nm
Spot Size Equivalence: 1.44 cm²	Identical. 1.44 cm²
Fluence Equivalence: 2-120 J/cm²	Identical. 2-120 J/cm²
Frequency Equivalence: 1-10 Hz	Identical. 1-10 Hz
Pulse Duration Equivalence: 9-143 ms	Identical. 9-143 ms
Power Supply Equivalence: AC 110V/50Hz-60Hz	Identical. AC 110V/50Hz-60Hz
Dimension Equivalence: 5959146 cm	Identical. 5959146 cm
Weight Equivalence: 49 kg	Identical. 49 kg
Biocompatibility: - No Cytotoxicity - No Sensitization - No Irritation	- Identical. No Cytotoxicity - Identical. No evidence of sensitisation - Identical. No evidence of irritation
Electrical Safety Compliance: - IEC 60601-1 - IEC 60601-2-22	Compliant. Comply with IEC 60601-1, IEC 60601-2-22
EMC Compliance: IEC 60601-1-2	Compliant. Comply with IEC 60601-1-2
Laser Safety Compliance: - IEC 60601-2-22 - IEC 60825	Compliant. Comply with IEC 60601-2-22, IEC 60825
Manufacturing Process/Components: Identical to predicate	Identical. Made by the same manufacturer, utilizing the same controls, components, and processes.

Study Proving Acceptance Criteria:

The "study" here is a set of non-clinical tests designed to confirm that the "New Era" device meets the established design specifications and is indeed substantially equivalent to the predicate device.

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size: This is not a study with a "test set" in the sense of a dataset of patient images or clinical outcomes. Instead, it refers to the physical device (New Era, Model FG2000) itself, against which engineering and safety tests were performed.
Data Provenance: Not applicable in the context of clinical data. The tests are performed on the device hardware. The document states the proposed device is "made by the same manufacturer" as the predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable. Ground truth for device specifications and compliance with engineering standards is established through validated testing procedures and compliance with international standards (e.g., IEC, ISO). These do not typically involve human expert interpretation in the way AI model ground truth is established.

4. Adjudication Method for the Test Set:

Not applicable. This is not a clinical study requiring human reader adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. An MRMC study was not done. This 510(k) is for a laser device for hair reduction, not an AI-assisted diagnostic tool. No AI component is described.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This is not an AI algorithm. It is a standalone medical device (laser).

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by:
- Engineering Specifications: The design specifications of the device parameters (e.g., wavelength, fluence, spot size, power supply).
- International Standards: Compliance with recognized consensus standards (IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10). These standards themselves define the "ground truth" for safety and performance requirements.
- Predicate Device Specifications: The "New Era" device's specifications were compared to those of the predicate device (FG2000D) to demonstrate identity.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no AI, there is no training set or associated ground truth establishment for a machine learning model.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

K182604

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)

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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

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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

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EmergencySwitch	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 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.

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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

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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

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	Handpiece	Handpiece	Handpiece	SE
	Foot Control	Foot Control	Foot Control	SE
Principle ofOperation	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

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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
PatientContact	Sapphire in handpiece andhandpiece tip	Sapphire in handpiece andhandpiece tip	SE
Materials	(Stainless Steel)	(Stainless Steel)
Cytotoxicity	No Cytotoxicity	No Cytotoxicity; no evidence ofsensitization or irritation
Sensitization	No evidence ofsensitization		SE
Irritation	No evidence of irritation
EMC, Electrical and Laser Safety
ElectricalSafety	Comply with IEC 60601-1,IEC60601-2-22	Comply with IEC 60601-1, IEC60601-2-22	SE

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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.

Regulation Number and Section

§ 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.