# K955612: RD-1200H Normal Mode Ruby Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical Technologies, Inc.
- Decided: Jul 9, 1996 after 214 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1,548 later devices descend from it; 2 cite it directly.
0 of 1,549 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) pre-enactment normal mode ruby laser devices: named in the summary without a submission number
- (no number) post enactment devices: named in the summary without a submission number

## Most influential descendants
- K963947: Epilaser Normal Mode Ruby Laser (1997), 1,546 descendants of its own
- K973324: Starlight Pulsed Diode Array Laser System (1997), 1,535 descendants of its own
- K982940: Lightsheer Pulsed Diode Array Laser System (1999), 1,526 descendants of its own
- K980517: Epilaser Normal Mode Ruby Laser (1998), 1,509 descendants of its own
- K962446: Sharplan Ruby Laser System (1997), 1,497 descendants of its own

## Indications for use
The Spectrum Epilaser® has severa: indications for use based on the selective absorption of natural chromophores. particuiarly melanin and tattoos. The Ruby laser wavelength of 694.3 nanometers and the pulse duration of the normal mode system are well absorbed by these pigments. Indications for use include the treatment of benign epidermal pigmented lesions such as lentigines and café au lait and tattoos (blue and black)

Source page: https://510kreport.com/device/K955612
Methodology: https://510kreport.com/methodology