Product Code: FTD
FDA class 2
21 CFR 878.4580
Lamp, Surgical
General, Plastic Surgery
A surgical lamp is a general-purpose lighting device used to illuminate the operative field during surgical procedures, providing high-intensity and focused light for the surgical team. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FTD, regulated under 21 CFR 878.4580, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
510(k)s
29
FEI Numbers
59
Registration Numbers
59
Unique Applicants
25
Years Active
37
Basic Information
- Product Code
- FTD
- Device Class
- FDA class 2
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 29 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K133425 | SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT | Dec 05, 2013 | Substantially Equivalent | ENGINEERED MEDICAL SOLUTIONS CO. LLC. |
| K130513 | VOLISTA 400; VOLISTA 600 | May 08, 2013 | Substantially Equivalent | MAQUET SAS |
| K123776 | POLARIS 100/200 | Mar 08, 2013 | Substantially Equivalent | DRAGER MEDICAL GMBH |
| K111020 | ATRICURE DISSECTOR | Jun 09, 2011 | Substantially Equivalent | ATRICURE, INC. |
| K100234 | HM-LAMP II | Jul 08, 2010 | Substantially Equivalent | HILLUSA, INC. |
| K100884 | STRYKER KNIFELIGHT | Jun 25, 2010 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K071180 | SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 | Jun 20, 2007 | Substantially Equivalent | ENGINEERED MEDICAL SOLUTIONS CO. LLC |
| K053364 | HALUX IRIS EXAMINATION AND SURGICAL LAMP | Feb 23, 2006 | Substantially Equivalent | WALDMANN LIGHTING |
| K041681 | ATRICURE DISSECTOR | Jul 01, 2004 | Substantially Equivalent | ATRICURE, INC. |
| K013242 | AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM | Dec 13, 2001 | Substantially Equivalent | STERIS Corporation |
| K010724 | SOLA 700,SOLA 500, SOLA 300 | Jun 07, 2001 | Substantially Equivalent | DRAGER MEDIZINTECHNIK GMBH |
| K003423 | ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 | Feb 22, 2001 | Substantially Equivalent | ST. FRANCIS MEDICAL EQUIPMENT CO., LTD. |
| K981717 | STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR | Jun 30, 1998 | Substantially Equivalent | STRYKER INSTRUMENTS |
| K961122 | STRYKER KNIFELIGHT | Aug 22, 1996 | Substantially Equivalent | STRYKER INSTRUMENTS |
| K954263 | XE-LITE | Oct 18, 1995 | Unknown | OPHTHALMIC TECHNOLOGIES, INC. |
| K942553 | GENESIS | Jun 23, 1994 | Substantially Equivalent | BURTON MEDICAL PRODUCTS CORP. |
| K931675 | MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS | Feb 22, 1994 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K932451 | HANAULUX 2005 SURGICAL LIGHT | Nov 12, 1993 | Substantially Equivalent | HERAEUS INSTRUMENTS GMBH |
| K930897 | MI-15 EXAM SURGICAL LIGHT | Jun 25, 1993 | Substantially Equivalent | MEDICAL ILLUMINATION, INC. |
| K895715 | HANAULUX(R) 2000 | Oct 13, 1989 | Substantially Equivalent | W.C. HERAEUS GMBH |
| K882613 | ALM SURGICAL LAMPS | Jul 18, 1988 | Substantially Equivalent | ALM SURGICAL EQUIPMENT, INC. |
| K860088 | PL EXAM LIGHT | Jan 24, 1986 | Substantially Equivalent | BURTON MEDICAL PRODUCTS CORP. |
| K841360 | MINOR SURGICAL LIGHT MODEL 180 | Apr 24, 1984 | Substantially Equivalent | AMERICAN STERILIZER CO. |
| K823360 | SURGICAL LIGHT | Dec 03, 1982 | Substantially Equivalent | AMSCO CO. |
| K811728 | CASTLE & RITTER MINOR SURG. & EXAM LT | Jul 20, 1981 | Substantially Equivalent | SYBRON CORP. |
| K801353 | PARKE-DAVIS SURGICAL LIGHT | Jun 30, 1980 | Substantially Equivalent | WARNER-LAMBERT CO. |
| K770861 | SURGICAL COLDLIGHT, AX8 | Jun 17, 1977 | Substantially Equivalent | AFFILIATED HOSPITAL PRODUCTS, INC. |
| K770568 | SURGICAL ILLUMINATOR (SIL) | Apr 14, 1977 | Substantially Equivalent | FIBER OPTICS ENGINEERING, INC. |
| K770567 | LIGHT, EXAMINATION, MEDICAL (MEL) | Apr 14, 1977 | Substantially Equivalent | FIBER OPTICS ENGINEERING, INC. |
FEI Numbers
This FDA classification entry is associated with 59 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 59 registration numbers. Click on an entry to view related FDA registrations.