The CLS001 Laser System is intended to effect stable, long-term or permanent hair reduction, in Fitzpatrick skin types I-VI, including sun tanned skin types. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing after a treatment regime
The CLS001 Laser System is intended to effect coagulation and haemostatis of vascular lesions in Fitzpatrick skin types I-VI, including suntanned skin types.

Device Description

The CLS001 Laser System is an analog, pulsed Nd: YAG laser utilizing the Nd: YAG crystal as the lasing medium. It operates at the wavelength of 1064 nanometers. Laser activation is controlled by a footswitch mechanism. Physically, the system weighs 66 pounds, is 13.8 inches high, 23.6 inches wide and 17.3 inches deep. The electrical requirements are 220/240 VAC single phase, 50/60 Hz and 8 amps.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the K112141 device:

Based on the provided 510(k) summary for the Castle Laser Systems Limited CLS001 Laser System, the following information can be extracted:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety	"as safe...as the other devices in its class, the Smartepil and the Depilase."
Effectiveness	"as effective as the other devices in its class, the Smartepil and the Depilase."
Intended Use	"effect stable, long-term or permanent hair reduction, in Fitzpatrick skin types I-VI; including sun tanned skin types." "effect coagulation and haemostatis of vascular lesions in Fitzpatrick skin types I-VI, including suntanned skin types."
Technological Characteristics	Nd: YAG laser, 1064 nanometers wavelength.
Manufacturing Compliance	"Manufactured according to cGMP per Guide to CGMP, WHO/VSQ/97.02"

Note: The document explicitly states "Clinical Performance Data: none required." This indicates that the device's acceptance criteria for safety and effectiveness were established through substantial equivalence to predicate devices, rather than through new clinical performance studies demonstrating a specific level of clinical outcome (e.g., a specific percentage of hair reduction or lesion clearance).

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No clinical test set was used for this device's performance evaluation as clinical performance data was "none required."
- Data Provenance: Not applicable for a clinical test set. The substantial equivalence argument relies on the established safety and efficacy of the predicate devices (Smartepil and Depilase Yag Lase Plus).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set requiring expert ground truth was performed for this device.
Adjudication method for the test set:
- Not applicable. No clinical test set was performed.
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:
- Not applicable. This device is a medical laser system, not an AI-assisted diagnostic or imaging device, and no MRMC study was conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical laser system, not an algorithm, and the performance evaluated was substantial equivalence to predicate devices.
The type of ground truth used:
- The "ground truth" for the device's performance is implicitly the established safety and effectiveness of the legally marketed predicate devices. The manufacturer argued that their device is substantially equivalent to these predicates. The specific type of ground truth (e.g., pathology, outcomes data) for the predicate devices' original clearances is not detailed in this document, but their prior clearance implies their performance met a certain standard.
The sample size for the training set:
- Not applicable. There is no mention of a "training set" in the context of an algorithm or AI for this device. The regulatory submission relies on substantial equivalence.
How the ground truth for the training set was established:
- Not applicable. No training set was used.

Summary

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KII 2141
Page 1 of 2

APR 1 3 2012

510(k) Summary

Castle Laser Systems Limited

Submitter's Contact Information

Name:	Raymond R. Blanche
Address	NST Consulting, LLC641 Shunpike Road, Suite 311Chatham, New Jersey, 07928
Telephone:Facsimile:	(973) 539-7444(973) 539-7445
Name of Device and Name/Address of Sponsor
Trade Name:	CLS001 Laser System
Sponsor ContactInformation:	David SmithCastle Lasers Systems Limited64 Dudley StreetBedfordBedfordshire, MK40 3TBUnited Kingdom
Common or Usual Name:	Medical Laser System
Classification Name:	Instrument, surgical, powered, laser79-GEX21 CFR 878.48

Predicate Devices:

Device Trade Name 1 Sinch

Manufacturer

Smartepil Depilase Yag Lase Plus Cynosure, Inc. Depilase Group Ltd

Date Prepared:

July 15, 2011 Updated April 12, 2012

· ·

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Intended Use / Indications for Use

The CLS001 Laser System is indicated to effect stable, long-term or permanent hair reduction, in Fitzpatrick skin types I-VI; including sun tanned skin types. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing after a treatment regime The CLS001 Laser System is intended to effect coagulation and haemostatis of vascular lesions in Fitzpatrick skin types I-VI, including suntanned skin types.

Technological Characteristics

Performance Data:

Clinical Performance Data: none required

Non-clinical Performance Data: Manufactured according to cGMP per Guide to CGMP, WHO/VSQ/97.02

Substantial Equivalence ' ' ' ' '

The CLS001 Laser System is as safe and effective as the other devices in its class, the Smartepil and the Depilase. The sponsor believes that with the exception of the configuration of the predicate devices, the devices are identical in the key areas that effect safety and efficacy. Both The sponsor believes that the difference in the physical appearance or in the method of delivering the radiant energy of the device systems is of no consequence and does not effect the therapeutic value or the safety profile. The sponsor believes that the difference between the devices is limited to the method of controls. The CLS001 is an analog system and the predicate devices are digital, microprocessor controlled systems. The CLS001 laser system is another safe and effective Nd: YAG laser intended to effect stable, long-term or permanent hair reduction, in Fitzpatrick skin types I-VI, including sun tanned skin types. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing after a treatment regime The CLS001 Laser System is intended to effect coagulation and haemostatis of vascular lesions in Fitzpatrick skin types I-VI. including suntanned skin types. Therefore, the CLS001 Laser System satisfies the FDA's substantial equivalence criteria and should be granted a 510(k) clearance for marketing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Castle Laser Systems, LTD % NST Consulting, LLC Mr. Raymond R. Blanche Managing Member 641 Shunpike Road, Suite 311 Chatham, New Jersey 07928

APR 1 3 2012

Re: K112141

Trade/Device Name: Caste Laser Long Pulse Nd: YAG CLS001 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: February 28, 2012 Received: March 7, 2012

Dear Mr. Blanche:

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r hat 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

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Page 2 - Mr. Raymond R. Blanche

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,

Eunice Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number: k 112141

Device Name: Castle Laser Long Pulse Nd:YAG Laser CLS001

Indications for Use:

The CLS001 Laser System is intended to effect coagulation and haemostatis of vascular lesions in Fitzpatrick skin types I-VI, including suntanned skin types.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED)

Concurrence of CDRH, Office of device Evaluation (ODE)

Prescription Use __ X (Part 21 CFR 801 Subpart D) OR

Over-the -Counter Use

Neilkohl for mxn
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112141

Premarket Notification for the Castle Laser System CLS001

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.