Cleared Traditional

K033768 - ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE

K033768 is an FDA 510(k) clearance for ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE, manufactured by Altus Medical, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K033768 · Altus Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
76d
Days
Class 2
Risk

K033768 is an FDA 510(k) clearance for the ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Altus Medical, Inc. (Burlingame, US). The FDA issued a Cleared decision on February 17, 2004 after a review of 76 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K033768

510(k) Number K033768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2003
Decision Date February 17, 2004
Days to Decision 76 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 116d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Consultant

Underwriters Laboratories, Inc.
MORTEN CHRISTENSEN

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.

Regulatory Peers - ILY Lamp, Infrared, Therapeutic Heating

All 228
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K033768.
MLT-1000 IR LASER SYSTEM
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TH0R DDII IR LAMP SYSTEM
K033923 · Thor Intl. · Mar 2004
KENKOWAVE INFRARED PAIN TREATMENT SYSTEM
K033555 · Kaylight Corporation · Mar 2004
ALT LASER, MODEL VTR 75
K031612 · Avicenna Laser Technology, Inc. · Dec 2003
LIGHTWAVE INFRARED LAMPS LW10D AND LW30D
K024027 · Skytech Enterprises, Inc. · Dec 2003
QUASAR, MODEL MD21
K032379 · Quantum Skincare, Inc. · Nov 2003

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K033768 · ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE
Download PDF FDA Summary Altus Medical, Inc.