Cleared Traditional

K152280 - BioPhotas Celluma3

K152280 is an FDA 510(k) clearance for BioPhotas Celluma3, manufactured by Biophotas, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K152280 · Biophotas, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
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Mar 2016
Decision
203d
Days
Class 2
Risk

K152280 is an FDA 510(k) clearance for the BioPhotas Celluma3. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Biophotas, Inc. (Tustin, US). The FDA issued a Cleared decision on March 2, 2016 after a review of 203 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Biophotas, Inc. devices

FDA 510(k) Submission Details - K152280

510(k) Number K152280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2015
Decision Date March 02, 2016
Days to Decision 203 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 116d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Physical Medicine devices follow this clearance model.

Regulatory Consultant

Qpm Consulting, LLC
ROBERT SEIPLE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02543970 Completed Observational Industry-sponsored

A Confirmatory Study for Evaluation of the Treatment by the Celluma3 of Periorbital Wrinkles

42
Patients (actual)
Condition studied Wrinkled Structure
Eligibility All sexes · 30 Years+ · Healthy volunteers accepted
Principal investigator Jesse Mitchell, MD, FAAD
Sponsor BioPhotas (industry)
Started 2015-02-01 → Primary completion 2015-08-01
Primary outcome
Reduction of Periorbital Wrinkles
Study completed - no results published. This trial concluded in 2015 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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All 195
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