BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NATURALASE LP ND:YAG LASER

    K Number: K031828 · Decision Jul 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    103
    Applicant Total
    9
    Review Days
    34

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NATURALASE LP ND:YAG LASER
    K Number
    K031828
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Focus Medical, LLC
    Date Received
    June 13, 2003
    Decision Date
    July 17, 2003
    Product Code
    GEN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEN Forceps, General & Plastic Surgery

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GEN), ordered by most recent decision date.

    FORCEPS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SUTURE REMOVING FORCEPS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    FORCEPS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PALPATION PROBE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    GS-1002 GRASPING FORCEP, 5MM WITH RATCHET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    GS-1200 GRASPING/EXTRACTING FORCEP, 10MM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Focus Medical, LLC

    K Number Device Name
    K152737 Lite Touch
    K152529 NaturaLase CO2 Laser System
    K151473 NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module
    K110333 NATURALASE CO2 LASER SYSTEM
    K101152 NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810
    K041829 FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS
    K032667 FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)
    K992597 LORAD LT-100 LASER TREATMENT SYSTEM