(254 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The device description focuses on hardware components and the performance studies describe clinical safety and effectiveness without mentioning algorithmic performance.
No.
Explanation: The device is intended for "hair removal" which is generally considered an aesthetic or cosmetic purpose, not a therapeutic one. It's listed as an "over-the-counter device" and its intended use is "adjunctive use with shaving for hair removal."
No
The "Intended Use / Indications for Use" states that the device is "intended for adjunctive use with shaving for hair removal sustained with periodic treatments," which is a treatment function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including a base unit, handpiece, and chiller system, indicating it is not a software-only device.
Based on the provided information, the ABC Hair Removal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for adjunctive use with shaving for hair removal sustained with periodic treatments." This describes a physical treatment applied to the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The components listed (base unit, handpiece, chiller system, etc.) are consistent with a device that physically interacts with the body for hair removal, not a device that analyzes biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The ABC Hair Removal System does not fit this description.
N/A
Intended Use / Indications for Use
The ABC Hair Removal System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.
Product codes (comma separated list FDA assigned to the subject device)
GEX, OHT
Device Description
The ABC Hair Removal System is composed of a base unit, umbilical cord, handpiece, chiller system with chiller coolant, cleaning wipes, ABC lubricant, power supply and safety components.
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
over-the-counter device
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)
Clinical data was collected in a prospective clinical study to support the safety and effectiveness of the ABC Hair Removal System for over-the-counter use. The clinical studies demonstrated that the ABC System functions as intended with no serious adverse events.
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
060839
510(k) Summary ABC Hair Removal System
DEC - 7 2006
This 510(k) summary is being submitted in accordance with 21 CFR 807.92
SUBMITTER'S INFORMATION 1.
| NAME: | Palomar Medical Technologies, Inc. |
|---|---|
| ADDRESS: | 82 Cambridge Street |
| Burlington, MA 01803 | |
| Phone: (781) 993-2300 | |
| Fax: (781) 993-2330 | |
| CONTACT: | Sharon Timberlake, RAC, CCRA |
| Director, Clinical & Regulatory Affairs |
DATE PREPARED: October 26, 2006
2. DEVICE INFORMATION
| TRADE/PROPRIETARY NAME: | ABC Hair Removal System |
|---|---|
| COMMON/USUAL NAME: | Light Based Hair Removal System |
| CLASSIFICATION NAME: | Laser surgical instrument for use in general and |
| plastic surgery and in dermatology | |
| (21 CFR §878.4810) |
Product Code: GEX
3. PREDICATE DEVICES
·
SpaTouch® PhotoEpilation System (K020856) Radiancy (Israel) Ltd.
Spectra Hair Removal Laser (K052848) SpectraGenics, Inc.
Palomar SLP™ 1000 (K013028) Palomar Medical Technologies, Inc.
1
060839
4. INTENDED USE
The ABC Hair Removal System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.
ട്. DEVICE DESCRIPTION
The ABC Hair Removal System is composed of a base unit, umbilical cord, handpiece, chiller system with chiller coolant, cleaning wipes, ABC lubricant, power supply and safety components. Details are provided in the Device Description Section of this submission.
PERFORMANCE & CLINICAL DATA 6.
The device complies with the following U.S. Food and Drug Administration performance standards: 21 CFR §1040.10 & 1040.11. Clinical data was collected in a prospective clinical study to support the safety and effectiveness of the ABC Hair Removal System for over-the-counter use. The clinical studies demonstrated that the ABC System functions as intended with no serious adverse events.
7. SUBSTANTIAL EQUIVALENCE
The ABC Hair Removal System is substantially equivalent to its predicate devices when intended for use for hair removal. The data in this 510(k) notification demonstrate that the ABC System shares the same intended use, and similar design features and functional features, and therefore is substantially equivalent to its predicate devices. Details are provided in the Substantial Equivalence Section of this submission.
2
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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2008
Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake, RAC, CCRA Director of Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803
Re: K060839
Trade/Device Name: ABC Hair Removal System 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: OHT Dated: July 24, 2006 Received: July 25, 2006
Dear Ms. Timberlake:
This letter corrects our substantially equivalent letter of December 7, 2006.
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 (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.
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 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); good manufacturing practice requirements as set
3
Page 2 - Ms. Sharon Timberlake, RAC, CCRA
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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Neil R.P. Ogden
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ___ K060839
Device Name: ABC Hair Removal System
Indications for Use:
The ABC Hair Removal System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ro
Sign-Off Division of General, Restorative. and Neurological Devices
510(k) Number 060835
OR
Over-The-Counter Use X
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
PALOMAR MEDICAL TECHNOLOGIES, INC. ABC HAIR REMOVAL SYSTEM 510(K)
CONFIDENTIAL