(148 days)
K011677, 014234
Not Found
No
The description focuses on the physical conversion of laser wavelengths and does not mention any computational or algorithmic processes indicative of AI/ML.
Yes.
The device is indicated for various medical treatments such as tattoo removal, treatment of vascular lesions, pigmented lesions, and incision, excision, ablation, and vaporization of soft tissue in dermatology, all of which are considered therapeutic applications.
No
The text describes a laser accessory used for treatment procedures on soft tissue, including tattoo, vascular, and pigmented lesion removal, as well as incision, excision, ablation, and vaporization. There is no mention of the device being used for diagnosis.
No
The device description clearly states that the device is a "Hand Piece Adapter and the Dye Pack Accessory" which are physical components that attach to a laser, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states that this device is a laser accessory used for various dermatological treatments performed directly on the patient's body (tattoo removal, treatment of vascular and pigmented lesions, soft tissue incision, excision, ablation, and vaporization).
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient.
Therefore, this device falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 532 Hand Piece Adapter and the Dye Pack Accessories (Red or Yellow), when attached to the NaturaLase 1064 Laser, are indicated for:
Tattoo removal
Red inks (532 nm Hand Piece Adapter)
Blue and light blue inks (Yellow Dye Pack)
Green inks (Red Dye Pack)
Treatment of Vascular Lesions - Using the 532 nm Hand Piece Adapter
Port wine birthmark
Telangiectasias
Spider angiomas
Cherry angiomas
Spider nevi
Treatment of Pigmented Lesions - Using the 532 nm Hand Piece Adapter
Café-au-lait birthmarks
Solar lentigines
Senile lentigines
Becker's nevi
Freckles
Nevus spilus
Nevus of ota
Incision, excision, ablation, and vaporization of soft tissue in dermatology - Using the 532 Hand Piece Adapter.
Product codes
GEX
Device Description
The Focus Medical 532 Hand Piece Adapter and the Dye Pack Accessory are accessories to the NaturaLase 1064 O-Switched laser. The 532 Hand Piece Adapter converts the 1064 nm Iaser energy of the NaturaLase to 032667 2/2 The Red Dye Pack Accessory converts the 532 532 nm laser energy. nm laser energy to a red beam (595-660 nm) and the Yellow Dye Pack Accessory converts the 532 nm laser energy to a yellow beam (568 - 590 nm).
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
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
Performance Data: None required. The claim of substantial equivalence is based on comparisons of specifications, characteristics, and indications for use of the claimed predicates.
Key Metrics
Not Found
Predicate Device(s)
Continuum Medlite C3 (K011677) and C6 Q-Switched (014234) Nd:YAG lasers
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
SECTION 9
JAN 2 3 2004
510(k) SUMMARY
This 510(k) summary of safety and effectiveness for the Focus Medical 532 Hand Piece Adapter alone or with the Dye Pack Accessory (red or yellow) for use with the NaturaLase 1064 laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
-
Applicant: Focus Medical
Address: 23 Francis J. Clarke Circle Bethel, CT 06801 -
Manufacturer: Focus Medical
-
Contact Person: John B. Lec, Jr. President Focus Medical
-
Telephone: 203-730-8885
Preparation Date: August 2003 (of the Summary)
-
Device Name: Focus Medical 532 Hand Piece Adapter and Dye Pack Accessory (red or yellow)
Common Name: Accessories to the Natural.ase 1064 O-Switched Laser -
Classification: Laser surgical instrument for use in general and plastic surgery and in dermatology
Class II medical device 21 CFR 878.4810
Product Code: GEX Panel: 79
- Predicate devices: Continuum Medlite C3 (K011677) and C6 Q-Switched (014234) Nd:YAG lasers
- Device description: The Focus Medical 532 Hand Piece Adapter and the Dye Pack Accessory are accessories to the NaturaLase 1064 O-Switched laser. The 532 Hand Piece Adapter converts the 1064 nm Iaser energy of the NaturaLase to
1
032667 2/2
The Red Dye Pack Accessory converts the 532 532 nm laser energy. nm laser energy to a red beam (595-660 nm) and the Yellow Dye Pack Accessory converts the 532 nm laser energy to a yellow beam (568 - 590 nm).
Indications: The 532 Hand Piece Adapter and Dye Pack Accessory (Red or Yellow), when attached to the NaturaLase 1064 Laser, are indicated for:
Tattoo removal
Red inks (532 nm Hand Piece Adapter) Blue and light blue inks (Yellow Dye Pack) Green inks (Red Dye Pack)
Treatment of Vascular Lesions - 532 nm Hand Piece Accessory Port wine birthmark Telangiectasias Spider angiomas Cherry angiomas Spider nevi
Treatment of Pigmented Lesions - 532 nm Hand Piece Accessory Café-au-lait birthmarks Solar lentigines Senile lentigines Becker's nevi Freckles Nevus spilus Nevus of ota
Incision, excision, ablation, and vaporization of soft tissue in general dermatology- 532 nm Hand Piece Accessory.
Performance Data: None required. The claim of substantial equivalence is based on comparisons of specifications, characteristics, and indications for use of the claimed predicates.
- CONCLUSION: Based on the information in the notification Focus Medical believes that the Focus Medical 532 Hand Piece Adapter and the Dye Pack Accessory (red or yellow) are substantially equivalent to the claimed predicates, i.e., Continuum Medlite C3 and C6 Q-Switched Nd:YAG lasers, under conditions of intended use as described in their user manuals.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2004
Mr. John B. Lee, Jr. President Focus Medical 23 Francis J. Clarke Circle Bethel, Connecticut 06801
Re: K032667 Trade/Device Name: Focus Medical the 532 Hand Piece Adapter and the Dye Pack Accessory (red or yellow) 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 12, 2003 Received: December 12, 2003
Dear Mr. Lee:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). 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 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 l'ederal 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 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.
3
Page 2 - Mr. John B. Lee, Jr.
This letter will allow you to begin 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Cclia 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
4
SECTION 7
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K032667
Device Name: Focus Medical the 532 Hand Piece Adapter and the Dye Pack Accessory (red or yellow).
The 532 Hand Piece Adapter and the Dye Pack Accessories (Red or Yellow), when attached to the NaturaLase 1064 Laser, are indicated for:
Tattoo removal Red inks (532 nm Hand Piece Adapter) Blue and light blue inks (Yellow Dye Pack) Green inks (Red Dye Pack)
Treatment of Vascular Lesions - Using the 532 nm Hand Piece Adapter Port wine birthmark Telangiectasias Spider angiomas Cherry angiomas Spider nevi
Treatment of Pigmented Lesions - Using the 532 nm Hand Piece Adapter Café-au-lait birthmarks Solar lentigines Senile lentigines Becker's nevi Freckles Nevus spilus Nevus of ota
Incision, excision, ablation, and vaporization of soft tissue in dermatology - Using the 532 Hand Piece Adapter.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use X | OR | Over-The Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | ||
| rev. 12/03 | Miriam C. Provost | |
| Division of General, Restorative | ||
| and Neurological Devices | 035 | |
| K032667 |