The Unica 315M R/G is indicated for use as a surgical instrument to vaporize, incise, excise, ablate or photocoagulate soft tissue in general surgical procedures

Device Description

Weight:	33 lb. (15 kg.)
Dimensions:	Length:19.6 in. (49 cm.)Height (folded arm):7.5 in. (18 cm.)Width:6.4 in. (16 cm.)
Main Laser Source:	CO2 laser, sealed wave guide tube TEM00.
Treatment BeamWavelength:	10,600 nm CO2 laser
Aiming BeamWavelength:	532 nm KTP or 635 nm GaAlAs-laser - max. output 5 milliwatt.
Modes of Operation*:	Superpulse/Pulse/ContinuousSingle or Repeat pulse trains
Beam Delivery:	4 joint articulated arm that can be partially folded into the laser.
Battery backup:	Equipped with backup battery for 1 to 5 hours of operationdepending on output power etc.
Battery charge cycle:	Full charge is achieved in 5 hours
Cooling system:	Internal cooling to instrument case. Overheat protection circuit.
Electric requirements:	Single phase 220-230V 50 Hz, <0.5A, orSingle phase 110-120V 60 Hz, <1.0A.
It contains a sealed laser tube, i.e. no gas filling is needed. The typical life time of the laser . tube is more than 10,000 hours of operation.
It is mechanically robust and electrically very safe does not contain any higher voltage . than 32 volts.
It is easy to transport. The 315 M can be hand-carried without difficulty. The articulated . arm can be partially folded into the laser.
It has a backup battery. The laser output is independent of any line voltage fluctuations or . even total voltage loss for hours.
It can be connected via micromanipulators to microscopes and colposcopes. Special accessories can be employed, e.g. for angular cutting.

AI/ML Overview

The provided text is a Summary of Safety and Effectiveness Information for the Reliant Technologies, Inc. Unica 315M R/G CO2 Laser System, submitted for 510(k) premarket notification. This type of document establishes substantial equivalence to already legally marketed devices, rather than conducting a de novo study to establish new acceptance criteria and prove performance against them.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets them, sample sizes, ground truth establishment, expert adjudication, or MRMC studies.

Instead, the document focuses on:

Device Description: Physical and operational characteristics of the Unica 315M R/G CO2 Laser System.
Intended Use: Broad application in general surgical procedures for soft tissue manipulation.
Comparison to Predicate Devices: A detailed table comparing the Unica 315M R/G CO2 Laser System's specifications and indications to three legally marketed predicate CO2 laser systems (Luxar - LX-20SP, Coherent System 451, Sharplan 1020).
Substantial Equivalence Argument: The core of the 510(k) submission, asserting that the Unica 315M R/G is as safe and effective as the predicate devices based on shared technological characteristics and intended use.

In summary, this document is a regulatory submission for premarket clearance based on substantial equivalence, not a clinical study report proving performance against defined acceptance criteria.

Therefore, I cannot provide the requested table and study details because the information is not present in the provided text.

Summary

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SEP 20 2 3

Summary of Safety and Effectiveness Information Reliant Technologies, Inc. Unica 315M R/G CO2 Laser System Safe Medical Devices Act of 1990, 21CFR807.92

1. Device Name(s)

Trade Name:	Unica 315M R/G CO₂ Surgical Laser System
Common Name:	CO₂ Surgical Laser
Classification Name:	Instrument, Surgical, Powered, Laser§ 878.4810 Laser surgical instrument for use in general and plastic surgery and dermatology. Classification: Class II.
Classification Panel:	General & Plastic Surgery Devices Panel
Product Code(s):	79-GEX

2. Establishment Name & Registration Number:

Reliant Technologies, Inc. Name:

Number: 2950711

3. Special Controls:

This device complies with CDRH radiation control regulations as outlined in:

21 CFR §1040, Performance Standards for Light Emitting Products

21 CFR §1010, Performance Standards for Electronic Products, general.

4. Labeling:

The Unica 315M R/G is indicated for use as a surgical instrument to vaporize, incise, excise, ablate or photocoagulate soft tissue in general surgical procedures.

Required laser warning and caution statements are displayed as required for surgical laser devices.

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5. Device Description:

Weight:	33 lb. (15 kg.)
Dimensions:	Length:19.6 in. (49 cm.)Height (folded arm):7.5 in. (18 cm.)Width:6.4 in. (16 cm.)
Main Laser Source:	CO2 laser, sealed wave guide tube TEM00.
Treatment BeamWavelength:	10,600 nm CO2 laser
Aiming BeamWavelength:	532 nm KTP or 635 nm GaAlAs-laser - max. output 5 milliwatt.
Modes of Operation*:	Superpulse/Pulse/ContinuousSingle or Repeat pulse trains
Beam Delivery:	4 joint articulated arm that can be partially folded into the laser.
Battery backup:	Equipped with backup battery for 1 to 5 hours of operationdepending on output power etc.
Battery charge cycle:	Full charge is achieved in 5 hours
Cooling system:	Internal cooling to instrument case. Overheat protection circuit.
Electric requirements:	Single phase 220-230V 50 Hz, <0.5A, orSingle phase 110-120V 60 Hz, <1.0A.

*Reliant Technologies, Inc. continually incorporates innovations into its products. Product specifications may change without notice.

It contains a sealed laser tube, i.e. no gas filling is needed. The typical life time of the laser . tube is more than 10,000 hours of operation.
It is mechanically robust and electrically very safe does not contain any higher voltage . than 32 volts.
It is easy to transport. The 315 M can be hand-carried without difficulty. The articulated . arm can be partially folded into the laser.
It has a backup battery. The laser output is independent of any line voltage fluctuations or . even total voltage loss for hours.

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It can be connected via micromanipulators to microscopes and colposcopes. Special accessories can be employed, e.g. for angular cutting.

Attachments/Accessories:

The Unica 315 M CO2 Laser is compatable with the following existing legally marketed Reliant Technologies, Inc. laser attachments and accessories:

1. UniMax Model 2000 Color Corrected MicroSpot CO2 Laser Micromanipulator -K920821.
1. Acutome 2000 Color Corrected Laparoscopic CO2 Laser Coupler and Sleeves K942868.
1. Acutome 100 Color Corrected CO2 Laser Handpiece K942931.
1. AccuScan Model C CO2 Laser Scanner K953670.

6. Applicant Name & Address:

Reliant Technologies, Inc. 1153 Triton Drive, Suite C Foster City, CA 94404 415.570.6831 - 415.377.0887 (fax)

7. Company Contact:

Ms. Lana Black Reliant Technologies, Inc. 1153 Triton Drive, Suite C Foster City, CA 94404 415.570.6831 - 415.377.0887 (fax)

8. Substantially Equivalent Device(s):

1. Luxar Corporation. LX-20SP Laser System
1. Coherent Laser Systems. System 451 CO2 Laser System
1. Laser Industries. Sharplan 1020 CO2 Surgical Laser System

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9. Equivalence:

Based on the long standing history of use of CO2 lasers and the operational and clinical parameters of the Unica 315 M and the referenced comparison devices, Reliant Technologies, Inc. believes that the Unica 315 M laser is substantially equivalent to devices presently legally marketed in the US.

10. Feature Comparison Table:

SPECIFICATION	UNICA 315M R/G CO2Laser System	Luxar - LX-20SPLaser System	CoherentSystem 451 CO2Laser System	Sharplan 1020 CO2SurgicalLaser System
LASER MEDIUM -WAVELENGTH:	CO2 -10.6 micron	CO2 -10.6 micron	CO2 -10.6 micron	CO2 -10.6 micron
BATTERY BACKUP:	1-5 hours depending onlaser output power	NA	NA	NA
OUTPUT Power:	1-15 Watt	2 - 20 Watt	0.5 - 100 Watt	1-20 Watt
MODE:	TEMoo, Gaussian	TEMo1, Multimode	TEMoo, Gaussian	TEMoo, Gaussian
Exposure Times:	Single pulse and variable,0.05 -continuous sec.	Single pulse and variable,0.05 -continuous sec.	Single pulse and variable,0.05 -continuous sec.	Single pulse and variable,0.05 -continuous sec.
POWERREQUIREMENTS:	110-120 VAC or220-240 VAC	110-120 VAC or220-240 VAC	117-220 VAC	120 VAC
AIMING BEAM:	635 nm GaA1As - up to 5mW532 nm up to 3 mW	NA	HeNe 0.8 mW- 632.8 nm	HeNe 2.0 mW- 632.8 nm
BEAM DELIVERY:	Articulated arm &accessories	Hollow waveguide	Articulated arm &accessories	Articulated arm &accessories
WEIGHT:	33 lb./15 Kg.	40 lb./18.4 kg	350 lb./160 kg	80 Ib./36 Kg
COOLING:	Air Cooled	Air Cooled	Water	Water
INDICATIONS:	Cutting, coagulation.excision and ablation of softtissue.	Cutting, coagulation,excision and ablation of softtissue.	Cutting, coagulation,excision and ablation of softtissue.	Cutting, coagulation,excision and ablation ofsoft tissue.
K Numbers:	Pending	K953074	K951812	K860087

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird-like figure with three distinct head profiles layered on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

SEP 2 5 1997

Ms. Lana Black .Vice President and Official Correspondent Reliant Technologies, Inc. 1153 Triton Drive, Suite C Foster City, California 94404

Re: K971821 Trade Name: Unica 315M R/G - CO, Surgical Laser System Regulatory Class: II Product Code: GEX Dated: August 21, 1997 Received: August 22, 1997

Dear Ms. Black:

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 (QS) 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 may 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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,

fccellge

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

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14971821

Indication for Use

The Unica 315M R/G is indicated for use as a surgical instrument to vaporize, incise, excise, ablate or photocoagulate soft tissue in general surgical procedures

Concurrence of CDRH, Office of Device Evaluation (ODE)

tcoello

(Division Sign-Off) Division of General Re-510(k) Number

Prescription Use V (Per 21CFR§801.109)

Over-The-Counter Use

Regulation Number and Section

§ 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.