OTC Indications and Usage: BIAFINE is indicated for management of superficial wounds such as minor scrapes, minor irritations, minor abrasions, minor blisters, 1st degree burns, minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, abrasions and minor burns. RX Indications and Usage: BIAFINE is indicated for management of full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers, radiation dermatitis, donor sites and 2nd degree burns. BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, abrasions and minor burns.

Device Description

BIAFINE Topical Cream is a white oil-in-water cream and is supplied in lined aluminum tubes with a screw-top closure. Ingredients: Purified water, liquid paraffin, ethylene glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalane, avocado oil, trolamine/sodium alginate, triethanolamine, cetyl palmitate, methylparaben (sodium salt), sorbic acid (as potassium salt), propyl paraben (sodium salt), and fragrance.

AI/ML Overview

The provided document is a 510(k) summary for the device BIAFINE Topical Cream. It aims to demonstrate substantial equivalence to predicate devices for expanded indications, particularly for Over-The-Counter (OTC) use. The document doesn't present a traditional acceptance criteria table with reported device performance in a numerical format often seen in AI/ML device studies. Instead, it relies on demonstrating equivalence through comparison of technological characteristics and supported by existing clinical literature.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria for device performance. Instead, it argues for substantial equivalence by comparing the technological characteristics of the subject device (BIAFINE Topical Cream) with predicate devices and by citing existing literature supporting the expanded indications. The "reported device performance" is essentially a qualitative claim of effectiveness and safety based on prior knowledge and published studies.

Acceptance Criterion (Implicit)	Reported Device Performance (Qualitative)
Technological Characteristics Equivalence:Indications for Use (Rx & OTC)Sterility ClaimMechanism of ActionDelivery System	Substantially Equivalent to Predicates:The technological characteristics of BIAFINE Topical Cream are identical or substantially equivalent to the predicate devices (K964240 BIAFINE, K153648 Microcyn Plus Skin & Wound Hydrogel, K090092 Sockit Dermal Gel, and K043063 OxyBand). All are non-sterile, water-based, preserved, semi-viscous formulations with similar indications and mechanisms (maintaining moist wound environment, except OxyBand which supplies oxygen).
Safety and Effectiveness for Expanded OTC Indications:Management of superficial wounds (cuts, scrapes, irritations, abrasions, blisters)1st degree burns (sunburns)Minor skin irritations (post non-ablative laser therapy, microdermabrasion, superficial chemical peels)Relief of itch, pain, burning from minor skin irritations, lacerations, abrasions, minor burns	Supported by Existing Literature and Clinical Studies:Multiple independent clinical studies and published literature on BIAFINE and predicate devices demonstrate effectiveness in wound management (post non-ablative laser procedures, chemical peeling, minor wounds, skin irritation, blisters) and relief of symptoms (burning, pain, itch). Specific studies cited showed successful management of side effects (crusting, redness, discomfort) and equivalency to petrolatum ointment in reducing redness and peeling. No serious complications or unexpected adverse effects were reported.
Preservative Effectiveness:Meet USP <51> criteria	Meets Criteria:Preservative effectiveness testing of BIAFINE Topical Cream was conducted as per USP <51> and met the criteria.
Shelf-life of opened product:Supported in-use stability	Supported:An in-use study was performed to support the shelf-life of the opened product.
Physico-chemical properties:pH, Residual testing, Sulfated Ash, Viscosity, Water Content	Meets Criteria:Limit testing for these properties was conducted to support the in-use study data and preservative efficacy as per USP <51>, and the results met the criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a single "test set" in the context of a prospective clinical trial with a defined sample size for the current submission. Instead, it leverages "multiple independent clinical studies" and "published literature" as evidence. These studies would have their own sample sizes and data provenance, but those details are not provided in this 510(k) summary. The clinical evidence is retrospective, drawing from previously published research and existing data on BIAFINE and similar products. The countries of origin of the data are not explicitly stated, but clinical studies are cited from various journals, and some references indicate locations such as Marseille, France.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. This information is not applicable in the context presented. The review relies on published clinical studies and expert consensus inherent in the existing medical literature, rather than establishing new ground truth for a discrete test set. The individual studies cited would have involved medical professionals, but their specific roles in "establishing ground truth" for a single test set are not detailed in this summary.

4. Adjudication Method for the Test Set

N/A. This information is not applicable as there is no mention of a defined "test set" with a need for adjudication in the traditional sense for this 510(k) submission. Evidence is drawn from published literature.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

N/A. An MRMC study is not mentioned. The document describes clinical studies that compared BIAFINE to a placebo or another product (like petrolatum ointment) in specific conditions, but not in the format of an MRMC study designed to evaluate human readers' improvement with AI assistance. This device is a topical cream, not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

N/A. This question is not applicable. The device is a topical cream, not an algorithm, so "standalone performance" in this context is irrelevant.

7. The Type of Ground Truth Used

The "ground truth" for the claims made in this submission is derived from:

Clinical outcomes and observations from numerous published independent clinical studies.
Expert consensus inherent in the medical literature and clinical practice regarding wound healing and the management of skin conditions.
Physiological measurements (e.g., reduction in erythema, edema) and patient-reported outcomes (e.g., relief of itch, pain, burning) from the cited studies.

8. The Sample Size for the Training Set

N/A. The concept of a "training set" is not applicable here as the submission is for a medical device (topical cream), not an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established

N/A. The concept of a "training set" is not applicable here as the submission is for a medical device (topical cream), not an AI/ML algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

August 13, 2018

Valeant Pharmaceuticals Esha Desai Senior Manager Regulatory Affairs 400 Somerset Corporate Boulevard Bridgewater, NJ 08807

Re: K173549 Trade/Device Name: Biafine Regulatory Class: Unclassified Product Code: FRO Dated: July 9, 2018 Received: July 11, 2018

Dear Esha Desai:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Federal 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good

{1}------------------------------------------------

manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (if known)

K173549

Device Name BIAFINE

Indications for Use (Describe)

OTC Indications and Usage:

BIAFINE is indicated for management of superficial wounds such as minor scrapes, minor irritations, minor abrasions, minor blisters, 1st degree burns, minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels.

BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, abrasions and minor burns.

RX Indications and Usage:

BIAFINE is indicated for management of full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers, radiation dermatitis, donor sites and 2nd degree burns.

BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, abrasions and minor burns.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments reqarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

1 510(k) SUMMARY

1. General Information

Submitter:	Contact Person:
Valeant Pharmaceuticals	Esha Desai
1400 North Goodman Street	400 Somerset Corporate Blvd.
Rochester, NY 14609	Bridgewater, NJ 08807
General Telephone: 585-338-5800	908-541-3273
	Esha.Desai@valeant.com

Preparation Date: August 13, 2018

1. Names

Device Name	BIAFINE Topical Cream
Classification Name	Dressing, Wound and Burn, Hydrogel W/Drug And/Or Biologic
Common Name:	Wound Dressing
Product Codes:	FRO
Performance Standards:	No performance standards for this device have been promulgated under Section 514, Federal Food, Drug and Cosmetics Act.

1. Predicate Devices
  BIAFINE cleared under K964240 on January 22, 1997 Microcyn Plus Skin and Wound Hydrogel cleared under K153648 on April 19, 2016. Sockit Dermal Gel cleared under K090092 on May 11, 2009

Reference Device OxyBand cleared under K043063 on March 24, 2005

1. Product Description
  The subject of this 510(k) submission is for the BIAFINE Topical Cream which is substantially equivalent to the predicate. BIAFINE Topical Cream is identical to the formulation, intended use, technology and the performance of the existing product currently commercialized.

Ingredients: Purified water, liquid paraffin, ethylene glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalane, avocado oil, trolamine/sodium alginate, triethanolamine, cetyl palmitate, methylparaben (sodium salt), sorbic acid (as potassium salt), propyl paraben (sodium salt), and fragrance.

{4}------------------------------------------------

BIAFINE is a white oil-in-water cream and is supplied in lined aluminum tubes with a screw-top closure.

1. Indications for Use

Rx Indications and Usage:

BIAFINE is indicated for management of full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers, radiation dermatitis, donor sites and 2nd degree burns.

BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, lacerations, abrasions and minor burns.

OTC Indications:

BIAFINE is indicated for management of superficial wounds such as minor cuts, minor scrapes, minor irritations, minor abrasions, minor blisters, 1st degree burns including sunburns, minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, lacerations, abrasions and minor burns.

1. Summary of Technological Characteristics
  The technological characteristics of the BIAFINE Topical Cream are substantially equivalent to those of the predicate devices. All three products are non-sterile water based, preserved, semi-viscous formulations which have similar indications for use and storage. BIAFINE and Microcyn retain a neutral pH, and are used topically in addition both contain humectant and emollient components which donate moisture to the skin.

	SubjectDevice	PredicateDevice	PredicateDevice	PredicateDevice	ReferenceDevice
Characteristic	SubjectDeviceBIAFINETopical Cream	K964240BIAFINETopical Cream	K153648Microcyn Skin& WoundHydrogel	K090092SockitDermal Gel	ReferenceDeviceOxyBand(K043063)
Intended Use	A wounddressing whichcreates a moistwoundenvironmentnecessary tothe healingprocess.	Identical assubject device	Identical assubject device	Identical assubject device	Identical assubject device
RxIndications forUse	BIAFINE isindicated forthemanagementof:	BIAFINE isintended to beused as awounddressing forthe following	Under thesupervision of ahealth careprofessionalMicrocyn PlusWound Gel is	This productprovides for themanagement ofand relieves thepain associatedwith all types of	ThePrescriptionOxyBand TMWoundDressings areintended to
• FullThicknessWounds• PressureSores• DermalUlcersincludinglower legulcers• RadiationDermatitis• Donor Sites2nd DegreeburnsBIAFINE mayalso be usedfor relief ofitch, pain andburning fromminor skinirritations,lacerations,abrasions andminor burns.	indications:SuperficialwoundsMinorAbrasionsLeg UlcersDonor Sites1st and 2nddegree burns,includingsunburnRadiationDermatitisDermal ulcersFull ThicknessWoundsPressure Sores	intended for themanagement ofpost nonablative lasertherapyprocedures, postmicrodermabrasion therapy andfollowingsuperficialchemical peels.Microcyn PlusWound Gelmay also beused to relieveitch and painfrom minor skinirritations,lacerations,abrasions andminor burns.	dermal wounds,skin sores,injuries andulcers of theskin.Examplesinclude:• All types ofdermal wounds,skin sores,injuries andulcers of theskin• First &Second degreeburns• Pressureulcers, stages I - IV• Stasis ulcers• Diabeticulcers• Radiationdermatitis• Post-surgicalincision• Surgical sites,including softtissue graft sites• Foot ulcers• Venous stasisulcers• Cuts &Abrasions• Partialthicknesswounds• Irritation ofthe skin• Itching• Sunburn• Skin conditionassociatedperiostomy care• Chemical peel• Tattooingprocedures• Irritation andpain followingskin Laserresurfacingtreatment• Irritation and	provide amoistenvironment tofacilitate thenormal woundhealingprocess.OxyBand ™WoundDressings canbe used tocover andprotectwounds andcatheter sitesor used as asecondarydressing forother woundproducts suchas gauze,alginates,hydrogels,debridementfacilitators, ora protectivecover over atrisk skin. TheOxyBand ™WoundDressings areindicated for:• Cleanclosedsurgicalincisions• Skin graftdonorsites• Stage I orII pressureulcers,pressuresores,Superficial woundssuchas abrasions,skin tears, andblisters,lacerations• First andsecond
				pain followingdermabrasiontherapy	degreeburns• Chafedskin, skincontinuouslyexposed tomoisture• Secondarydressingovergauze,alginates orhydrogels
OTCIndications forUse	BIAFINE isindicated formanagementof• SuperficialWounds suchas minor cuts,minor scrapes,minorirritations,minorabrasions andminor blisters• 1st Degreeburns,includingsunburns• Minor skinirritationsfollowing postnon ablativelaser therapyprocedures,microdermabrasion therapyor superficialchemicalpeels.BIAFINE mayalso be usedfor relief ofitch, pain andburning fromminor skinirritations,lacerations,abrasions andminor burns.	Same as Rxindications inclearanceletter.	Microcyn PlusWound Gel isintended for themanagement ofminor skinirritationsfollowing postnon ablativelaser therapyprocedures,microdermabrasion therapy orsuperficialchemical peels.Microcyn PlusWound Gelmay also beused to relieveitch and painfrom minor skinirritations,lacerations,abrasions andminor burns	This productprovides for themanagement ofand relieves thepain associatedwith all minordermal wounds,minor skinsores, minorinjuries andminor irritationsof the skin.Examplesinclude:• Minor burns• Minor Cuts &Abrasions• Superficialitching• Sunburn• Minor burnsfrom a chemicalpeel treatment• Minorirritation andpain followingtattooingprocedures• Minorirritation andpain followingskin laserresurfacingtreatment• Minorirritation andpain followingdermabrasiontherapy	The Over-The-CounterOxyBand™ WoundDressings areintendedto protectlight tomoderatewounds,including skintears, scrapes,minor pressuresores,abrasions,blisters,lacerations,minor bums, toprotect chafedor irritatedskin orskincontinuouslyexposed tomoisture, andto create amoistenvironmentforwoundhealing
Sterility Claim	Non-sterile	Identical assubject device	Identical assubject device	Non-sterileNaturalPreservativeGel from foodgradecomponents	Identical assubject device
Mechanism ofAction	Maintains amoist woundenvironment'	Identical assubject device	Identical assubject device	Identical assubjectdevice	Suppliesoxygen to thewound
DeliverySystem	Topical Cream	Identical assubject device	TopicalHydrogel	TopicalHydrogel	permeable gasemittingreservoir

Premarket Notification Traditional 510(k)

{5}------------------------------------------------

{6}------------------------------------------------

Premarket Notification Traditional 510(k)

BIAFINE Topical Cream

{7}------------------------------------------------

{8}------------------------------------------------

1. Safety and Effectiveness Information
  The review of the indications for use and technical characteristics provided demonstrates that BIAFINE Topical Cream is substantially equivalent to the predicate devices.
1. Performance Data
  Non-Clinical Performance Data:

Non-clinical testing was conducted to support the safety and effectiveness of BIAFINE Topical Cream. An in-use study was performed to support the shelf-life of opened product. Preservative effectiveness testing of BIAFINE Topical cream conducted as per USP <51>. The preservative effectiveness of BIAFINE Topical Cream meet USP <51> criteria. pH, Residual testing. Sulfated Ash. Viscosity and Water Content limit testing were conducted to support the In-Use study data and preservative efficacy as per USP <51> and the results meet the criteria as per USP <51>.

Clinical Performance Data:

Clinically, the expanded use of BIAFINE OTC for cosmetic procedures and blister indications and the current general use of the marketed BIAFINE is the same: to aid the natural wound healing process by providing an optimum moist environment. Cosmetic procedures such as post-laser therapy, chemical peeling and dermabrasion treatment stimulate like wound healing processes as each of these procedures enhance skin rejuvenation to fight signs of skin aging as well as treat various dermatologic pathologies. such as acne, melasma, and photodamage. 12 Whether a wound is acute or chronic, caused by pressure or burns, scientists and medical professionals recognize that a moist environment can support the natural process of wound healing in all types of wounds. 34 Therefore, the same data and results from BIAFINE prescription (Rx) product on wound healing as well as published literature on the benefits of BIAFINE in various wound types including minor blisters and minor skin irritations following post non-ablative laser therapy procedures, are considered applicable for support of expanded indications of BIAFINE for OTC (over the counter) use .

Multiple independent clinical studies have been reported in the scientific literature on BIAFINE. BIAFINE has been shown effective in wound management of post non-ablative laser procedures, 3,5,6,7,8,9,10 chemical peeling | and minor wounds, skin irritation, 177 10,11,12,13,14, and blisters,11,12,14,15 as well as relief of wound symptoms, such as burning, pain and itch.7,11,12,13,14,15

The results of the published studies on post laser treatment with BIAFINE showed successful management of the side effects (both signs and symptoms) from phototherapy, including crusting, redness, and temporary discomfort.7 A blinded pilot study evaluated erythema, edema and scarring with BIAFINE use post-laser treatment. 8 In another study, BIAFINE was used post 3DEEP non-ablative skin tightening treatment followed by a Fractional skin

{9}------------------------------------------------

resurfacing treatment. There were no incidences of infections, scarring, hyper/ hypopigmentation, or any other serious complications or any unexpected adverse effects were detected or reported. BIAFINE was tested in a single-center, split-face, double-blind, randomized trial comparing reduction of post treatment redness and peeling versus petrolatum ointment (PBO) after the Microlaser Peel procedure and a treatment with a 2940nm Er:YAG laser. In this study, BIAFINE achieved a reduction in redness and peeling and appears to be equivalent to PBO in resolving redness and peeling produced by MicroLaserPeel procedures.10

Published results from a randomized, single-center, double-blind, split-face clinical study evaluated BIAFINE compared to a placebo cream in 20 volunteers after 5-ALA (aminolevulinic acid) and PDT (photodynamic therapy) treatment. This study also evaluated subjective assessments for itching and tenderness. The assessments showed that BIAFINE topical emulsion appeared to be equivalent on itching, tenderness and peeling at Week 1.13 Relief of pain and itch from BIAFINE was also shown in several radiation dermatitis studies. One study compared BIAFINE versus petrolatum as supportive care for patients with head and neck cancer (HNSCC) undergoing radiation therapy with concurrent chemotherapy. The study was conducted to assess the anticipated skin reactions and subjective symptoms that regularly involve pain and itch (the same symptoms of pain, itch and burn that are associated with superficial wounds, minor abrasions, 1st degree burns, including sunburns) and blisters, one of the signs of radiation dermatitis. The study showed the use of BIAFINE can effectively manage the acute irradiation induced dermal injury and associated symptoms. 14

16

The collective safety data and the in-use clinical testing results found in the literature on blisters, relief of pain, itch, burn, and in non-ablative, chemical peel and dermabrasion procedures, demonstrates that the predicate devices (BIAFINE (510(k) K964240), OxyBand (510(k): K043063), Microcyn Plus Skin and Wound Hydrogel (510(k) K153648) and Sockit Dermal Gel (510(k) K090092) and the subject (BIAFINE OTC) device can be used effectively for the added indications.

References

1. Monheit. G. Chemical Peels. Skin Therapy Letter.com. Available at http://www.skintherapyletter.com/2004/9.2/2.html. Accessed September 25, 2017.
1. American Society for Dermatologic Surgery. Treatments and Procedures. Available at https://www.asds.net/Treatments/. Accessed September 25, 2017.
1. Field FK, Kerstein, MD. Overview of wound healing in a moist environment. Am J Surg. 1994; 167(1A):2S-6S.

{10}------------------------------------------------

1. Atiyeh BS, Ioannovich J, Al-Amm CA, El-Musa KA. Management of acute and chronic open wounds: the importance of moist environment in optimal wound healing. Curr Pharm Biotechnol. 2002; 3(3):179-95.
1. Brauer JA, Alabdulrazzaq H, Bae YS, Geronemus RG. Evaluation of a low energy, low density, non-ablative fractional 1927 nm wavelength laser for facial skin resurfacing. J Drugs Dermatol. 2015; 14(11):1262-7.
1. Laubach HJ, Tannous Z, Anderson RR, et al. Skin responses to fractional photothermolysis. Lasers Surg Med. 2006; 38:142-9.
1. Shamban AT. Combination hand rejuvenation procedures. Aesthet Surg J. 2009; 29(5):409-13.
1. Polder KD, Bruce S. Treatment of melasma using a novel 1,927-nm fractional thulium fiber laser: a pilot study. Dermatol Surg. 2012; 38(2):199-206.
1. Elman M, Frank I, Cohen-Froman H, Harth Y. Effective treatment of atrophic and icepick acne scars using deep non-ablative radiofrequency and multisource fractional RF skin resurfacing. J Cosmetics, Dermatol Sci and Appl. 2012; 2; 267-272.
1. Gold MH. A single-center, split-face, double-blind, randomized trial comparing reduction of post treatment redness achieved with a trolamine-containing topical emulsion versus petrolatum ointment after microlaser peel therapy. Conference paper presented at American Society for Laser Medicine and Surgery. 2007
1. Spitalier J, Amalric R, Value of Biafine in the Prevention and Treatment of Immediate Skin Reaction Following Radiotherapy. Marseille, France: Centre Regional De Lutte Contre Le Cancer: 1973:11.
1. Wang R, Wu F, Wang D, Liu K. Clinical Effect of Biafine in Preventing and Treating Radioactive Skin Destruction of Nasopharyngeal Carcinoma Patients Caused by Concurrent Intensity-Modulated Radiotherapy and Chemotherapy. Chin. J. Clin. Oncol. 2008; 5:58-63.
1. Garcia B. Goldman M. Gold M. Comparison of Pre- and/or Postphotodynamic Therapy and Intense Pulsed Light Treatment Protocols for the Reduction of Postprocedure-Associated Symptoms and Enhancement of Therapeutic Efficacy. J Drugs in Derm. 2007; 6(9):924-928.
1. Abbas H, Bensadoun R, Trolamine Emulsion for the prevention of radiation dermatitis in patients with squamous cell carcinoma of the head and neck. Support Care Cancer. 2012: 20(1):185-90.
1. Amalric R, Robert F, Report on Post-Marketing Therapeutic Experience with Biafine in Radiotherapy. Marseille, France: Department of Radiotherapy at Polyclinique Clairval; 1992:7.
1. Data on file.
1. Conclusion

{11}------------------------------------------------

BIAFINE Topical Cream shares similar indications for use, identical formulation, manufacturing process, design features, and functional features, and thus is substantially equivalent to, the predicate device BIAFINE. Additionally, Preservative Efficacy testing and In-Use study has been conducted to ensure the substantial equivalenceof the product. Thus, the proposed new indications and updated labeling does not adversely affect the performance of BIAFINE.

BIAFINE is substantially equivalent in intended use, technological characteristics and safety and efficacy to the Microcyn Plus Hydrogel (K153648) and Sockit Dermal Gel (K090092), and is therefore substantially equivalent.

Regulation Number and Section

N/A