Search Results
Found 3 results
510(k) Data Aggregation
K Number
K040055Device Name
POLYLASE LP
Manufacturer
DDC TECHNOLOGIES, INC.
Date Cleared
2004-04-07
(86 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DDC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- The POLYLASE LP PULSED DUAL OUTPUT LASER is intended to effect 1. TEMPORARY HAIR REDUCTION in skin types I-IV with 755 nm output wavelength) and skin types IV-VI with 1064 nm output wavelength.
- 2. The POLYLASE LP PULSED DUAL OUTPUT LASER is also intended to effect STABLE LONG-TERM, OR PERMANENT, HAIR REDUCTION in skin types I-III with use of 755 nm wavelength and skin types IV and V with use of 1064 nm wavelength through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
- 3. FOR PHOTOCOAGULATION AND HEMOSTASIS OF DERMATOLOGICAL VASCULAR LESIONS with 1064 nm output wavelength.
- 4. FOR INCISION/EXCISION OF SOFT BODY TISSUES IN DERMATOLOGY with 1064 nm output wavelength.
- 5. FOR NONABLATIVE WRINKLE REDUCTION AND SKIN COLLAGEN REJUVENATION with 1064 nm output wayelongth
Device Description
Not Found
Ask a Question
K Number
K020513Device Name
EPY-50
Manufacturer
DDC TECHNOLOGIES, INC.
Date Cleared
2002-05-16
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DDC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. The EPY-50 PULSED Nd: YAG LASER is intended to effect TEMPORARY HAIR REDUCTION in skin types I-IV.
2. The EPY-50 PULSED Nd: YAG LASER is also intended to effect STABLE LONG-TERM, OR PERMANENT, HAIR REDUCTION in skin types I-IV through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
3. VASCULAR LESIONS.
Device Description
Not Found
Ask a Question
K Number
K010715Device Name
AL-40
Manufacturer
DDC TECHNOLOGIES, INC.
Date Cleared
2001-10-04
(209 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DDC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1