(84 days)
Not Found
No
The summary describes a laser system for hair removal and does not mention any AI or ML components or functionalities.
Yes
The device is described as a laser system intended for the removal of unwanted body hair in dermatology, which is a therapeutic application.
No
The device is intended for the removal of unwanted body hair, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a "surgical laser" and includes physical components like an "optical fiber beam delivery system" and a "foot switch." This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in dermatology for the removal of unwanted body hair." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a surgical laser that delivers energy to the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The Sharplan Ruby Laser System is a therapeutic device used for a dermatological procedure.
N/A
Intended Use / Indications for Use
The Sharplan Ruby Laser System, with its fiber delivery system, is intended for use in dermatology for the removal of unwanted body hair.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Sharplan Ruby Laser System is a surgical laser which is capable of providing pulsed laser energy of a 694.3 nm wavelength in the free running mode through an optical fiber beam delivery system. While observing and directing the aiming beam (633 nm, HeNe), the treatment beam is administered by the physician through a foot switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
No new indications were sought in this premarket notification. Therefore, no clinical data was presented.
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
KG 2077
AUG 27 1997
510(k) Summary of Safety and Effectivemess Sharplan Lasers, Inc. Modified Ruby Laser System
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of Sharplan Modified Ruby Laser System is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device which is the SLS Chromos 694 QD Ruby Laser System.
- 1 . Sharplan Lasers, Inc. l Pearl Court Allendale, NJ 07401 George J. Hattub, Director of Regulatory Affairs/Quality Assurance June 3, 1997
-
- Model: Sharplan Model 5000 (Modified) EpiTouch Ruby Laser System
- Predicate Device: The SLS Chromos 694 QD Ruby Laser System (K962109) 3.
- Description: The Sharplan Ruby Laser System is a surgical laser which is capable of 4 . providing pulsed laser energy of a 694.3 nm wavelength in the free running mode through an optical fiber beam delivery system. While observing and directing the aiming beam (633 nm, HeNe), the treatment beam is administered by the physician through a foot switch.
- 5 . The Sharplan Ruby Laser System (modified, with its fiber delivery system ) is intended for use in dermatology for the removal of unwanted dark body hair. No new indications were sought in this premarket notification. Therefore, no clinical data was presented.
1
Slouk) Summary of Safety and Effectivemess Sharplan Lasers, Inc. Modified Ruby Laser System (continued)
- For the purpose of this 510(k) notification, the predicate and candidate laser devices, are 6. of the same technology and have the same intended use. Based upon an analysis of the overall performance characteristics for the devices, Sharplan Lasers, Inc. believes that no significant differences exist. Therefore, the modifications made to the Sharplan Ruby Laser System should not raise any concerns regarding its overall safety or effectiveness.
- This information was prepared for the sole purpose of compliance with the Advisory: Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
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 eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1997
Mr. George J. Hattub Director of Regulatory Affairs/Quality Assurance, CQE Sharplan Lasers, Inc.. . . . . . . . . . . . . . . . 1 Pearl Court Allendale, New Jersey 07401
Re: K972099 Trade Name: Sharplan EpiTouch Ruby Laser System Regulatory Class: II Product Code: GEX Dated: June 3. 1997 Received: June 4, 1997
Dear Mr. Hattub:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation inay result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
3
Page 2 - Mr. George J. Hattub
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely yours,
[signature]
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
)
ﻤﺴﺴﺴﺴﺴﺴﺴﺴﺴ
ﺴﻌﺔ
510(k) Number (If known): K972099
Device Name: Sharplan Ruby Laser System
Indications For Use:
The Sharplan Ruby Laser System, with its fiber delivery system, is intended for use in dermatology for the removal of unwanted body hair.
(Please Do Not Write Below This Line - Continue on Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Acolla
(Divisio of General Restorative Devices Division 2972099 510(k) Num
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use ____
(Optional Format 1-2-96)