Model 672-BD, Home Uvb Light Source (Jordan Light); Model 2400, 4 (6 Foot) Ho UV Light Source; Model 2600, 6 (6 Foot) Ho
FDA 510(k) K052660 · The Richmond Light Co.
510(k) numberK052660
Submission
- Device name
- Model 672-BD, Home Uvb Light Source (Jordan Light); Model 2400, 4 (6 Foot) Ho UV Light Source; Model 2600, 6 (6 Foot) Ho
- Applicant
- The Richmond Light Co.
Richmond, VA, US - Received
- September 27, 2005
- Decision date
- October 17, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTC – Light, Ultraviolet, Dermatological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4630
- Specialty
- General, Plastic Surgery
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| K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD…FTC · Traditional | Shanghai Sigma High-Tech Co., Ltd. | 12/19/2024SE |
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More from Psoria-Shield, Inc.
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| K812446 | SunlampFTC · Traditional | 10/13/1981SE |
Questions and answers
When was Model 672-BD, Home Uvb Light Source (Jordan Light); Model 2400, 4 (6 Foot) Ho UV Light Source; Model 2600, 6 (6 Foot) Ho cleared by the FDA?
Model 672-BD, Home Uvb Light Source (Jordan Light); Model 2400, 4 (6 Foot) Ho UV Light Source; Model 2600, 6 (6 Foot) Ho (K052660) received a 510(k) decision of Substantially Equivalent on October 17, 2005, 20 days after the submission was received.
What is the product code of K052660?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.