(60 days)
LAD-01/06
Not Found
No
The summary describes a laser ablation device with no mention of AI or ML capabilities, image processing, or data analysis that would typically indicate the use of such technologies.
No
The device is described as preparing the skin for a therapeutic application, rather than being therapeutic itself. It ablates the outer layer of skin to assist in the effectiveness of an OTC topical cream for local dermal anesthesia.
No.
The device is indicated for ablation of the skin, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly states it is a "portable, handheld, battery powered bern hismater" which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for ablation of the outer layer of the skin prior to applying a topical anesthetic. This is a physical intervention on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a laser used to remove the stratum corneum. This is a therapeutic or preparatory action, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of the LAD-08 is for ablation of the outer layer of the skin prior to the application of the roller and the cream, for local dermal anesthesia.
LAD-08 is indicated for ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.
Product codes
GEX
Device Description
The Norwood Abbey Model LAD-08 is a portable, handheld, battery powered bern hismater The Norwood Abbey Model LAD-60 is a portuois, handelength of 2.94 um and a beam diameter of I he radiant energy produced by thin itsel mas a m. spot-size of 6 mm at the treatment site. The radiation delivered by the device is sufficient to remove the stratum corneum of skin exposed to the treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
No additional studies have been performed on the LAD-08.
Key Metrics
Not Found
Predicate Device(s)
LAD-01/06
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
510(k) Summary of Safety And Effectiveness for Model LAD-08 13.
| 13.1 Submitter Information | FEB 2 0 2004 |
|---|---|
| Norwood Abbey Limited. | |
| 63 Wells Road | |
| Chelsea Heights Victoria 3196 | |
| Australia |
| Contact Person: | Paul Clark |
|---|---|
| Telephone No.: | +61-3-9782 7308 |
| Fax: | +61-3-9782 7334 |
13.2 Device Name
Laser surgical instrument for general and plastic surgery and in Classification Name: dermatology
LAD, model LAD-08 Proprietary Name:
13.3 Predicate Devices
LAD-01/06
13.4 Description of the Device
The Norwood Abbey Model LAD-08 is a portable, handheld, battery powered bern hismater The Norwood Abbey Model LAD-60 is a portuois, handelength of 2.94 um and a beam diameter of I he radiant energy produced by thin itsel mas a m.
spot-size of 6 mm at the treatment site. The radiation delivered by the device is sufficient to remove the stratum corneum of skin exposed to the treatment.
13.5 Intended Use
The intended use of the LAD-08 is for ablation of the outer layer of the skin prior to the The meended use of the EAD oo in roller and the cream, for local dermal anesthesia.
13.6 Clinical Studies
No additional studies have been performed on the LAD-08.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2, 0 2004
Mr. Paul Clark Quality and Regulatory Affairs Manager Norwood Abbcy Limited 63 Wells Road Chelsea Heights Victoria 3196 Australia
Re: K033962 Trade/Device Name: Epiture™ Easytouch, Model LAD-08 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: December 18, 2003 Received: December 22, 2003
Dear Mr. Clark:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because is retty pe issubstantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Tor use stated in the encrosure) to regars the Medical Device Amendments, or to comments provide to May 20, 1978, the enable with the provisions of the Federal Food, Drug, devices mat have been reculsentied in assee approval of a premarket approval application (PMA). alla Cosmetic Act (Act) that do not require appt to the general controls provisions of the Act. The r ou may, mercere, manver the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sce above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soo aoove) the existing major regulations affecting your device can may be subject to subli ductional venisons, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obancements 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 that ITA has made a determinations administered by other Federal agencies. You must of any irederal statutes and regulations and including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, and manufacturing practice requirements as set CFK Part 677), labeling (21 CFR Part 820); and if applicable, the electronic (200); and if applicable, the electronic (200 forth in the quality bytichly (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Paul Clark
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your article quivalence of your device to a legally premarket notification. The PDA midner of basification 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 If you desire specific advice for your active of the collection of the regulation entitled, Contact the Office of Complance at (301) ->>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> "Misbranding by relevence to premation notification of the Act from the Division of Small other general information on your responsion.com at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-ifremation http:// Manufacturers, International and Combailer Prosservedrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A. Mikkelson
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
3
3.2 Statement of Intended Use
Page __ of
510(k) Number (if known): K033962
Device Name: Epiture™ Easytouch, Model LAD-08
Indications for Use:
LAD-08 is indicated for ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use X (Per 21 CFR 801.109)
Over-The Counter Use
Mark N Millkum
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
03391
510(k) Number_