LogoFDA 510(k) Search
K Number
K972514
Device Name
LASEREX LP1532 PHOTOCOAGULATOR
Manufacturer
Ellex Medical Pty. Ltd.
Date Cleared
1997-10-03

(88 days)

Product Code
HQFHOF
Regulation Number
886.4390
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indication for use for this product are; - · Retinal Photocoagulation - · Pan Retinal Photocoagulation - · Photocoaqulation for Macular Degeneration · Laser Trabeculoplasty - - · Endophotocoagulation.
Device Description
The LP1532 is a compact, solid state laser photocoagulator intended for ophthalmic use. It produces laser energy intended to be directed into the eye by a suitably qualified physician, via a range of laser delivery accessories namely; - Laser Endoprobes . - Laser Indirect Ophthalmoscope . - Slitlamp Delivery Systems . The LP1532 is a frequency doubled Nd:YAG Laser operating in the visible green wavelength spectrum ( 532 nanometers ).
More Information

Alcon Ophthalas 532, Alcon EyeLite, Iris Occulite, Nidek Prima

Not Found

No
The document describes a laser photocoagulator and its intended uses and accessories. There is no mention of AI or ML technology in the device description, intended use, or any other section. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Yes.
The device is a laser photocoagulator used for various ophthalmic treatments, including retinal photocoagulation, photocoagulation for macular degeneration, and laser trabeculoplasty, all of which are medical procedures aimed at treating diseases or conditions.

No

This device is a laser photocoagulator intended for ophthalmic treatments such as retinal photocoagulation and laser trabeculoplasty, which are therapeutic procedures, not diagnostic ones.

No

The device description clearly states that the LP1532 is a "compact, solid state laser photocoagulator," which is a hardware device that produces laser energy. It also mentions various hardware delivery accessories.

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs analyze samples from the human body. The device description and intended use clearly indicate that this device is a laser photocoagulator used to directly treat the eye. It delivers energy into the eye for therapeutic purposes, not for analyzing biological samples.
  • The intended uses are therapeutic procedures. Retinal photocoagulation, pan retinal photocoagulation, photocoagulation for macular degeneration, laser trabeculoplasty, and endophotocoagulation are all medical treatments performed directly on the patient's eye.
  • The device description focuses on the laser technology and delivery systems. This aligns with a therapeutic device, not a diagnostic one that would involve sample handling and analysis components.

Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The intended uses for this product are;

  • Retinal Photocoagulation .
  • Pan Retinal Photocoagulation .
  • Endophotocoagulation.
  • Photocoagulation for Macular Degeneration .
  • . Laser Trabeculoplasty

A General Description of these Treatments are;
The intended uses for this product are:
Retinal treatments, including;

  • . Retinal Photocoagulation
  • Pan Retinal Photocoagulation .
  • Endophotocoagulation .

These treatments involve the destruction of neovascular complexes, to obliterate areas of microinfarction or capillary closure.

Retinal Photocoagulation will be carried out using principally the Slitlamp Delivery System accessory.

Pan Retinal Photocoagulation will be carried out using either of the Laser Indirect Ophthalmoscope or the Slitlamp Delivery System accessory.

Endophotocoagulation will be carried out using any one of the three variants of the endoprobe accessories, namely Straight, Curved or Aspirating Endooccular Probes.

Photocoagulation for Macular Degeneration involves the destruction of leaking vessels in the macular and paramacular region, and ultimately to produce a chorioretinal adhesion that will resist ongoing vitreoretinal traction. This treatment will be carried out using the slitlamp microscope mounted Slitlamp Delivery System accessory.

Laser Trabeculoplasty, the photocoagulation of the trabecular meshwork to create apertures and increase the flow of the aqueous humor in order to treat open-angle glaucoma. This treatment will be carried out using the slitlamp microscope mounted Slitlamp Delivery System accessory.

Product codes (comma separated list FDA assigned to the subject device)

HOF

Device Description

The LP1532 is a compact, solid state laser photocoagulator intended for ophthalmic use. It produces laser energy intended to be directed into the eye by a suitably qualified physician, via a range of laser delivery accessories namely;

  • Laser Endoprobes .
  • Laser Indirect Ophthalmoscope .
  • Slitlamp Delivery Systems .

The LP1532 is a frequency doubled Nd:YAG Laser operating in the visible green wavelength spectrum ( 532 nanometers ).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ophthalmic (Retina, Macula, Trabecular Meshwork)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Suitably qualified 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)

Not Found

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.

Alcon Ophthalas 532, Alcon EyeLite, Iris Occulite, Nidek Prima

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

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.

0

OCT - 3 1997

510 (K) SUMMARY

K972514

This is a 510(K) Summary in accordance with CFR 807.92.

SUBMITTERS NAME, ADDRESS: 1.

Taracan Pty Ltd trading in the USA as Laserex Systems 258 Halifax Street Adelaide, South Australia 5000 AUSTRALIA

Corresponding Official: Keith R. Degenhardt Managing Director/CEO 61-8-82236644 Telephone: Facsimile: 61-8-82326277

Signature

Date: 616 97

2. DEVICE NAME

Laserex Model LP1532.

3. PREDICATE DEVICE IDENTIFICATION

3.1 Name(s)

The predicate devices are:

    1. Alcon Ophthalas 532.
    1. Alcon EyeLite
    1. Iris Occulite
    1. Nidek Prima

3.2 Predicate Device Company

    1. Alcon Surgical Inc
    1. Alcon Surgical Inc
    1. Iridex Corporation Inc
    1. Nidek Medical Inc

1

INTENDED USES 4.

4.1 The intended uses for this product are;

  • Retinal Photocoagulation .
  • Pan Retinal Photocoagulation .
  • Endophotocoagulation. ●
  • Photocoagulation for Macular Degeneration .
  • . Laser Trabeculoplasty

4.2 A General Description of these Treatments are;

The intended uses for this product are:

Retinal treatments, including;

  • . Retinal Photocoagulation
  • Pan Retinal Photocoagulation .
  • Endophotocoagulation .

These treatments involve the destruction of neovascular complexes, to obliterate areas of microinfarction or capillary closure.

Retinal Photocoagulation will be carried out using principally the Slitlamp Delivery System accessory.

Pan Retinal Photocoagulation will be carried out using either of the Laser Indirect Ophthalmoscope or the Slitlamp Delivery System accessory.

Endophotocoagulation will be carried out using any one of the three variants of the endoprobe accessories, namely Straight, Curved or Aspirating Endooccular Probes.

Photocoagulation for Macular Degeneration involves the destruction of leaking vessels in the macular and paramacular region, and ultimately to produce a chorioretinal adhesion that will resist ongoing vitreoretinal traction. This treatment will be carried out using the slitlamp microscope mounted Slitlamp Delivery System accessory.

Laser Trabeculoplasty, the photocoagulation of the trabecular meshwork to create apertures and increase the flow of the aqueous humor in order to treat open-angle glaucoma. This treatment will be carried out using the slitlamp microscope mounted Slitlamp Delivery System accessory.

2

DEVICE DESCRIPTION 5.

5.1 General

The LP1532 is a compact, solid state laser photocoagulator intended for ophthalmic use. It produces laser energy intended to be directed into the eye by a suitably qualified physician, via a range of laser delivery accessories namely;

  • Laser Endoprobes .
  • Laser Indirect Ophthalmoscope .
  • Slitlamp Delivery Systems .

The LP1532 is a frequency doubled Nd:YAG Laser operating in the visible green wavelength spectrum ( 532 nanometers ).

5.2 Specifications

Size:

Width:12" (310 mm)
Length:20" (510 mm)
Height:7.5" (190 mm)
Weight:37 lbs (17 kg)

Power/Electrical Requirements:

Voltage:110 or 220 VAC
Frequency:50 or 60 Hz
Electrical power:450 Watts
Insulation class:Class 1 (UL 2601-1)

Laser Characteristics:

Treatment laser beam
Laser class:Class IV (4)
Laser wavelength:532 nm
Laser power:30 mW min, 2 W max.

Aiming laser beam

Laser class: Class II (2) Laser wavelength: 635 nm Laser power: 0.05 to 0.95 mW

3

Significant Changes/Modifications from Predicate Device 5.3

There are no significant changes or modifications from the predicate products that affect safety, effectiveness, or the intended use of the product.

5.4 Accessories

The following accessories are intended for use with the LP 1532 laser :

  • Laser Endo Probes. .
  • Slitlamp Delivery System. ●
  • . Laser Indirect Ophthalmoscope.

Additional information is provided in the table below

| | 510 (K)
DEVICE | PREDICATE DEVICE | | | |
|------------------------------------|--------------------------------------------|---------------------------------------|---------------------------------------|----------------------------------------|--------------------------------------------|
| CHARACTERISTIC
COMPARED | LASEREX
LP-1532 | ALCON
OPHTHALAS
532 | IRIS | NIDEK | ALCON
EyeLite |
| Accessories | | | | | |
| Endo Probes | Straight,
curved and
aspirating | Straight,
curved and
aspirating | Straight and
curved
available | Endo
Probes
available | Straight,
curved and
aspirating |
| Laser Indirect
Ophthalmo-scope | Adapted
Heine | Adapted
Keeler Fison | Adapted
Heine | Nidek LIO | Adapted
Keeler Fison |
| Slitlamp Adaptors | To fit
• Zeiss
• Haag
Streit | To fit
• Zeiss
• Haag
Streit | To fit
• Zeiss
• Haag
Streit | To fit
• Zeiss
• Haag
Streit | To fit
• Zeiss
• Haag
Streit |
| | Combo for
use with
Laserex YAG | Combo for
use with
Laserex YAG | | Combo for
use with
NIDEK
YAGs | |
| Spot Size | 50-500
microns | 50-1000
microns | 75- 500
microns | | |
| Operating
Microscope
Filters | • Zeiss
• OPMI-6
• Wild
• Möeller | | | | • Zeiss
• OPMI-6
• Wild
• Möeller |

4

DEVICE LABELS 6.

Refer to Appendix A for all device labelling information including;

  • . Advertising brochure
  • . Description and directions for use
  • Product labels (including accessories) .

COMPARATIVE INFORMATION 7.

The following table displays the similarities and differences of the new device to the legally marketed devices to which equivalency is claimed.

5

| | 510(k)
DEVICE | PREDICATE DEVICES | | | |
|------------------------------------|------------------------------------------------------|-------------------------------------------|----------------------------|---------------------------------|--------------------------------------------------------------------------|
| Characteristic
Compared | LASEREX
LP-1532 | ALCON
OPHTHALAS
532 | IRIS
OCCULITE | NIDEK
PRIMA | ALCON
EyeLyte |
| Laser Power
(W) | Up to 2W | Up to 3W | Up to 1.2W | 1.5W | Up to 1.7W |
| Laser
Wavelength
(nm) | 532nm | 532nm | 532nm | 532nm | 532nm |
| Laser Class | IV | IV | IV | IV | IV |
| Exposure
Time (sec) | 0.01 to 2.0
sec | 0.01 to 2.0
sec and CW | 0.05 to 1.0
sec | 0.02 to 3 sec | 0.01 to 2.0
sec and CW |
| Aiming Laser
Type | Red Diode | HeNe | Red Diode | Red Diode | Red Diode |
| Aiming Laser
Power | 0.05 to 0.95
mW
continuously
variable | 4 intensities
selectable up
to 1 mw | 0 to1mW | 0.2 to 0.8mW | Continuously
variable up to
1 mw |
| Aiming
Wavelength | 635nm | 633nm | set between
630 - 650nm | 633nm | 670nm |
| Electrical
Supply
Voltage | 100-120VAC
220-250VAC
single phase
50/60 Hz | 220 VAC
single phase | 90-240 VAC
50/60 Hz | 100/120/
230 VAC
50/60 Hz | 100-120 VAC
8 A single
phase
220-240 VAC
4 A
single phase |
| Electrical
Power
Consumption | 450W | 3K W | 300W | 1500W | 800 W |
| Weight | 17Kg | 99Kg | 8.1Kg | 32Kg | 16Kg |
| Size | W 31cm
D 51cm
H 19cm | W 36cm
D 81cm
H 80cm | W.30cm
D 15cm
H 30cm | W 30cm
D 42cm
H 70cm | W 38.7cm
D 44.6 cm
H 21.8 cm |
| Environment | | | | | |
| Temperature | 15 - 35
degrees C | 15 - 30
degrees C | not specified | 5 - 35
degrees C | 15 - 35
degrees C |
| Humidity | Up to 85%
RH | Up to 85% RH | not specified | 5 - 95% RH
non
condensing | Up to 85%
RH |

6

| Repeat
Interval
Duration | Selectable
0.1,0.2,0.3,0.5,
0.6,0.7,
0.8,0.9,1.0
sec | Selectable
0.2, 0.5, 0.7,
0.9 sec | Selectable | 0.2 to 1.0 sec
in to 0.1 sec
intervals | Selectable
0.1, 0.2, 0.3,
0.4, 0.5, 0.6,
0.8, 0.9,1.0
sec |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cooling | Air cooled | Internal
water
cooling
system | Air cooled | Internal water
cooling
system | Air cooled |
| Scientific
concepts that
form the
basis for the
device | - Green laser source

  • Generated by means
    of a laser diode
    pumped, frequency
    doubled Yag laser.
  • Diode pumping
    configuration very
    efficient, permitting air
    cooling
  • Energy controlled
    by means of an
    operator by means of
    a software driven
    control system
  • Energy delivered to
    target tissue by a
    range of fiberoptic
    beam delivery
    systems | - Green laser source
  • Generated by means
    of an arclamp pumped,
    frequency doubled Yag
    laser.
  • Arclamp pumping
    configuration relatively
    inefficient, requiring
    closed loop water
    cooling
  • Energy controlled by
    means of an operator
    by means of a software
    driven control system
  • Energy delivered to
    target tissue by a range
    of fiberoptic beam
    delivery systems | - Green laser source
  • Generated by
    means of a laser
    diode pumped,
    frequency doubled
    Yag laser.
  • Diode pumping
    configuration very
    efficient, permitting
    air cooling
  • Energy controlled
    by means of an
    operator by means of
    a software driven
    control system
  • Energy delivered to
    target tissue by a
    range of fiberoptic
    beam delivery
    systems | - Green laser source
  • Generated by means
    of an arclamp
    pumped, frequency
    doubled Yag laser.
  • Arclamp pumping
    configuration relatively
    inefficient, requiring
    closed loop water
    cooling
  • Energy controlled by
    means of an operator
    by means of a
    software driven control
    system
  • Energy delivered to
    target tissue by a range
    of fiberoptic beam
    delivery systems | - Green laser source
  • Generated by means
    of a laser diode
    pumped, frequency
    doubled Yag laser.
  • Diode pumping
    configuration very
    efficient, permitting air
    cooling
  • Energy controlled by
    means of an operator
    by means of a
    software driven control
    system
  • Energy delivered to
    target tissue by a range
    of fiberoptic beam
    delivery systems |
    | Intended
    Uses | Retinal
    photocoagulation
    Panretinal
    photocoagulation,
    Photocoagulation for
    Macular Degeneration
    Trabeculoplasty
    Endophotocoagulation | Panretinal
    photocoagulation,
    Photocoagulation for
    Macular Degeneration
    Subretinal
    neovascularization,
    Trabeculoplasty,
    Pneumatic retinopexy,
    Retinal tears,
    Retinal detachments,
    Transscleral
    cyclophotocoagulation,
    Endophotocoagulation | Retinal
    photocoagulation,
    Anterior segment
    procedures. | Retinal
    photocoagulation,
    Subretinal
    neovascularization,
    Closing of retinal
    arteriols. | Panretinal
    photocoagulation,
    Photocoagulation for
    Macular Degeneration
    Subretinal
    neovascularization,
    Trabeculoplasty
    Pneumatic retinopexy
    Retinal tears
    Retinal detachments
    Endophotocoagulation |

7

BIOCOMPATIBILITY AND STERILIZATION INFORMATION 8.

The laser endo probe accessories are the only components of the device that are patient contacting and supplied sterilized.

We are sourcing these probes from:

Creative Medical Products, Inc 5988 Mld Rivers Mail Drive Suite 236 St Charles MO 63304

Owner/Operator Registration No. 9023612 Establishment Registration No. 1933418

They have provided the following information to us regarding the 510(K) approvals for these probes;

  • FDA 510(K) approval number #K954307 applies to the straight and curved . probes.
  • . FDA 510(K) approval number # K954308 applies to the aspirating laser probes.

These are the only probes we will be supplying with the device. Additional information provided by Creative Medical Products Inc is contained in Appendix B.

8

SOFTWARE VALIDATION & VERIFICATION 9.

In accordance with the Reviewer Guidance for Computer Controlled Medical Devices a review of the level of concern for the LP-1532 has been identified to be Minor to Moderate. Operation of the LP-1532 directly affects the patient such that failures or latent design flaws may result in Minor to Moderate patient injury.

The software development process has not yet been completed but we believe that an equivalence determination can be made prior to completion. The following data is provided in Appendix C. *

  • System and software requirements and design .
  • . Software development
  • . Verification and validation

I certify that in my capacity as Managing Director/CEO of Taracan Pty Ltd, I will ensure that the described processes will be completed and the following will be completed;

  • Test results and analysis
  • Software certification
    Signed:__. The text is a signature.

Name: Keith R. Degenhardt Position: Managing Director Date:

  • Derived from 510(K) Memorandum # K91-1 Software Documentation Matrix.

9

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of a human figure with three faces in profile, stacked on top of each other. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" printed around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 1997

Mr. Keith R. Degenhardt Managing Director Laserex Systems 258 Halifax Street Adelaide, South Australia 5000 AUSTRALIA

K972514 Re: Laserex LP1532 Photocoagulator Trade Name: Requlatory Class: II Product Code: HOF June 6, 1997 Dated: Received: July 7, 1997

Dear Mr. Degenhardt:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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.

10

Page 2 - Mr. Keith R. Degenhardt

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 requlation 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.qov/cdrh/dsmamain.html".

Sincerely yours

to colle

Witten, Ph.D., M.D. a M. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

11

510(k) Number (if known): K972514

vice Name: LASEREX LP1532 PHOTOCOAGULATOR

Indications For Use:

INDICATIONS FOR USE

The indication for use for this product are;

  • · Retinal Photocoagulation
  • · Pan Retinal Photocoagulation
  • · Photocoaqulation for Macular Degeneration · Laser Trabeculoplasty
  • · Endophotocoagulation.

A General Description of these Treatments are;

The indications for use for this product are: Retinal treatments, including;

  • Retinal Photocoaqulation .
  • . Pan Retinal Photocoaqulation
  • . Endophotocoagulation

These treatments involve the destruction of neovascular complexes, to obliterate areas of microinfarction or capillary closure.

Retinal Photocoagulation will be carried out using principally the Slittamp Delivery System accessory.

Pan Retinal Photocoagulation will be carried out using either of the Laser Indirect Ophthalmoscope or the Slitlamp Delivery System accessory.

Endophotocoagulation will be carried out using any one of the endoprobe accessories. namely Straight, Curved or Aspirating Endooccular Probes.

Photocoagulation for Macular Degeneration involves the destruction of leaking vessels in the macular and paramacular region, and ultimately to produce a chorioretinal adhesion that will resist ongoing vitreoretinal traction. This treatment will be carried out using the sittlamp microscope mounted Slittlamp Delivery System accessory.

Laser Trabeculoplasty, the photocoagulation of the trabecular meshwork to create apertures and increase the flow of the aqueous humor in order to treat open-angle glaucoma: This treatment will be carried out using the slitlamp microscope mounted Slitlamp Delivery System accessory.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (

Acseffe

(Division Sign-On)
Division of General Restorative Devices
510(k) Number K972814

Prescription Use
(21 CFR 801.109)

Over-The-Counter Use