(63 days)
Not Found
No
The summary describes a standard CO2 laser device and does not mention any AI or ML components or functionalities.
Yes
The device is described as being used for "treatment of such skin conditions as fine and coarse wrinkles, scars of various origin, uneven pigmentation and dilated pores" and to "achieve the purpose of treatment," indicating it has a therapeutic function.
No
The device description and intended use clearly state that it is used for treatment purposes (tissue vaporization, coagulation, skin improvement) rather than for diagnosing conditions. The performance studies also focus on safety and compliance with standards for therapeutic laser equipment.
No
The device description clearly identifies the device as a "Trixel CO2 Laser," which is a hardware-based medical device that uses a laser beam for treatment. The summary also mentions bench tests verifying compliance with hardware safety standards (IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the equipment is used for "human tissue vaporization, coagulation" in various surgical and aesthetic procedures. This is a direct therapeutic intervention on living tissue, not an in vitro test performed on samples outside the body.
- Device Description: The description details how the CO2 laser interacts with the skin's surface to cause peeling and stimulate regeneration. This is a physical interaction with the body, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device performs a therapeutic action directly on the body.
N/A
Intended Use / Indications for Use
The equipment is used for human tissue vaporization. coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology,
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Trixel CO2 Laser is a carbon dioxide laser used in medical and aesthetic industry for treatment of such skin conditions as fine and coarse wrinkles, scars of various origin, uneven pigmentation and dilated pores. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and use photothermolysis to stimulate deep cell regeneration and then achieve the target of skin improvement.
The equipment is mainly used for human tissue vaporization, coagulation and exposure to achieve the purpose of treatment.
CFL-10 Trixel CO2 Laser:
The equipment includes the following:
One mainframe;
One footswitch; One data cable;
One power wire;
One ventilation tube;
Six Wire clips;
Two keys:
One trixel (bitmap) scanner handpiece;
Two trixel laser position heads
One ordinary treatment handpiece with aimed light
A laser goggles;
Three 3.15A fuses;
One user manual.
UFL-60 Trixel II CO2 Laser:
The equipment includes the following:
One mainframe;
One set of footswitch; One data cable; One power wire: One ventilation tube; Six Wire clip; Two keys; One trixel (bitmap) scanner handpiece; Three trixel laser position heads; One ordinary treatment handpiece with aimed light A laser goggles; Three SA fuses; One user manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology
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)
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60825-1: 2007, Safety of laser products Part 1: Equipment classification, requirements. .
- . IEC 60601-2-22: 2007, Medical Electrical Equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.
- . IEC 60601-1:1988+A1:1991+A2:1995, Medical Electrical Equipment - Partl: General requirements for safety.
- . IEC60601-1-2:2001+A1:2004, Medical Electrical Equipment - Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.
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
Page (1) of (4)
Section III 510(k) Summary
Project #: MIDI INK0382010Bd
1 9 2011
Section III 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number:
-
Date of Submission: 2010.12.21 2. Sponsor Beijing Syntech Laser Co., Ltd. 5F, No.1 Building, No.65 Jiancaicheng West Road, Xisanqi, Haidian District, Beijing, 100096, P.R.China Contact Person: Jin Jinghua Position: Vice general manager Tel: +86-10-82939866-234 Fax: +86-10-82935528 Email: sales@syntechlaser.com
-
Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
-
Proposed Device Identification
Proposed Device Name: Trixel CO2 Laser/ Trixel II CO2 Laser Proposed Device Model: CFL-10/ UFL-60
Classification: 2 Product Code: GEX Regulation Number: 21 CFR 878.4810 Review Panel: 878 General and Plastic Surgery
Intended Use Statement:
The equipment is used for human tissue vaporization. coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology,
1
K110434 Page (2) of
Section III 510(k) Summary
- US agent
U.S. Agent Contact Name WEI HUANG
U.S. Agent Business Name MID-LINK INTERNATIONAL, INC.
U.S. Agent Full Address 307 EAGLE HEIGHTS APT E, MADISON, WISCONSIN, 53705, UNITED STATES
U.S. Agent E-mail info@mid-link.net
U.S. Agent Phone Number 608 -3355979
U.S. Agent Fax Number 760 -4665084
- Predicate Device Identification
510(k) Number: K101555 Product Name: CO2 LASER SYSTEM Manufacturer: ADVANCED TECHNOLOGY LASER CO., LTD.
7. Device Description
Trixel CO2 Laser is a carbon dioxide laser used in medical and aesthetic industry for treatment of such skin conditions as fine and coarse wrinkles, scars of various origin, uneven pigmentation and dilated pores. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and use photothermolysis to stimulate deep cell regeneration and then achieve the target of skin improvement.
The equipment is mainly used for human tissue vaporization, coagulation and exposure to achieve the purpose of treatment.
CFL-10 Trixel CO2 Laser:
The equipment includes the following:
One mainframe;
One footswitch; One data cable;
One power wire;
One ventilation tube;
Six Wire clips;
Two keys:
One trixel (bitmap) scanner handpiece;
Two trixel laser position heads
One ordinary treatment handpiece with aimed light
A laser goggles;
Three 3.15A fuses;
One user manual.
UFL-60 Trixel II CO2 Laser:
The equipment includes the following:
One mainframe;
2
Premarket Notification 510(k) Submission
Section III 510(k) Summary
One set of footswitch; One data cable; One power wire: One ventilation tube; Six Wire clip; Two keys; One trixel (bitmap) scanner handpiece; Three trixel laser position heads; One ordinary treatment handpiece with aimed light A laser goggles; Three SA fuses; One user manual.
8. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60825-1: 2007, Safety of laser products Part 1: Equipment classification, requirements. .
- . IEC 60601-2-22: 2007, Medical Electrical Equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.
- . IEC 60601-1:1988+A1:1991+A2:1995, Medical Electrical Equipment - Partl: General requirements for safety.
- . IEC60601-1-2:2001+A1:2004, Medical Electrical Equipment - Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.
Substantially Equivalent Conclusion 9.
The proposed device, Trixel CO2 Laser/Trixel H CO2 Laser, has same Product Code, Regulation Number. Class. Maximum Power. Work Mode. Wavelength. Mode Structure, Spot Size, Pulse Setting, etc., but only different in five aspects as following:
- … Intended Use
-
- Light Arm
-
- Aiming Beam
-
- Cooling System
- న్న Power Input
For these different, we have performed analysis as following:
Analysis 1 the intended use of predicate device includes the one of proposed device. They both have the function of vaporization and coagulation. The above clearance for intended use does not introduce any problems regarding the safety and effectiveness of the device.
3
Avalysis 2: though the length of light arm is different. CFL-10: 0.97m. UFL-60: 1.17m, predicate device: 1.3m. it doesn't affect the treatment itself. This difference does not introduce any problems regarding the safety and effectiveness of the device.
See analysis 3: Both the output range of aiming beam is